2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225

  
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PhaseCountries
1NCT05395624
(ClinicalTrials.gov)
February 2, 202313/5/2022A Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer), After Intravenous Administration to Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)Amyotrophic Lateral Sclerosis (ALS)Drug: 18F-OP-801Ashvattha Therapeutics, Inc.NULLRecruiting18 Years80 YearsAll26Phase 1United States
2NCT05695521
(ClinicalTrials.gov)
January 30, 20233/1/2023Regulatory T Cells for Amyotrophic Lateral SclerosisPhase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled TrialAmyotrophic Lateral SclerosisBiological: CK0803;Other: ExcipientCellenkos, Inc.NULLNot yet recruiting18 Years95 YearsAll66Phase 1United States
3NCT04505358
(ClinicalTrials.gov)
January 202323/7/2020Evaluate PU-AD in Subjects With Amyotrophic Lateral SclerosisA Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Biological Activity, Safety, and Pharmacokinetics of PU-AD in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: PU-AD;Drug: PlaceboSamus Therapeutics, Inc.NULLWithdrawn20 Years80 YearsAll0Phase 2NULL
4NCT05619783
(ClinicalTrials.gov)
December 29, 202227/10/2022Extension Study Evaluating The Safety And Tolerability of AMX0035A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants With Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)Amyotrophic Lateral SclerosisDrug: AMX0035Amylyx Pharmaceuticals Inc.NULLEnrolling by invitation18 YearsN/AAll600Phase 3Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom
5EUCTR2022-002348-33-ES
(EUCTR)
22/12/202227/09/2022A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
Other descriptive name: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Belgium;Poland;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
6NCT05633459
(ClinicalTrials.gov)
December 16, 202221/11/2022A Study Evaluating the Safety and Tolerability of QRL-201 in ALSA Multi-Center, Randomized, Double-Blind Placebo Controlled Multiple-Ascending Dose Study to Evaluate the Safety and Tolerability of QRL-201 in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: QRL-201 - Dose 1;Drug: QRL-201 - Dose 2;Drug: QRL-201 - Dose 3;Drug: QRL-201 - Dose 4;Drug: QRL-201 - Dose 5;Drug: QRL-201 - Dose 6;Drug: QRL-201 - Dose 7;Drug: QRL-201- Dose 8QurAlis CorporationNULLRecruiting18 Years80 YearsAll64Phase 1Canada
7NCT05683860
(ClinicalTrials.gov)
December 14, 20224/1/2023Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)ALS;FTDDrug: WVE-004Wave Life Sciences Ltd.NULLEnrolling by invitationN/AN/AAll42Phase 1/Phase 2Netherlands
8EUCTR2022-002348-33-NL
(EUCTR)
06/12/202211/10/2022A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-0A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
Other descriptive name: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
9NCT05189106
(ClinicalTrials.gov)
December 5, 202230/11/2021Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket TrialNeurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Proof of Concept Trial Including Asymptomatic Individuals Using BaricitinibAmyotrophic Lateral Sclerosis;Alzheimer Disease;Mild Cognitive ImpairmentDrug: BaricitinibMassachusetts General HospitalNULLRecruiting18 Years90 YearsAll20Phase 1/Phase 2United States
10NCT05003921
(ClinicalTrials.gov)
December 20226/8/2021Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALSSafety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: AlloRxThe Foundation for Orthopaedics and Regenerative MedicineNULLSuspendedN/AN/AAll20Phase 1Antigua and Barbuda
11NCT05597436
(ClinicalTrials.gov)
November 19, 202224/10/2022Intermediate-Sized Expanded Access StudyAn Expanded Access Protocol of Intravenous Trehalose Injection 90.5 mg/mL Treatment of Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: TrehaloseSeelos Therapeutics, Inc.Massachusetts General Hospital;National Institute of Neurological Disorders and Stroke (NINDS);Office of the Director, National Institutes of Health (OD)Temporarily not available18 YearsN/AAllUnited States
12NCT05407324
(ClinicalTrials.gov)
November 15, 20222/6/2022Dazucorilant in Patients With Amyotrophic Lateral SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)Amyotrophic Lateral SclerosisDrug: Dazucorilant 300 mg;Drug: Dazucorilant 150 mg;Other: PlaceboCorcept TherapeuticsNULLRecruiting18 YearsN/AAll198Phase 2Belgium;France;Netherlands;Poland
13NCT02988297
(ClinicalTrials.gov)
November 20227/12/2016Nebulized RNS60 for the Treatment of Amyotrophic Lateral SclerosisNebulized RNS60 for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: RNS60;Drug: PlaceboRevalesio CorporationNULLNot yet recruiting18 Years80 YearsAll140Phase 2NULL
14NCT05508074
(ClinicalTrials.gov)
November 202227/7/2022Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)A Double-blind, Placebo-controlled, Exploratory Randomised Clinical Trial to Assess the Safety and Efficacy of IFB-088 Plus Riluzole 100 mg vs Placebo Plus Riluzole 100 mg in Patients With Bulbar-onset Amyotrophic Lateral Sclerosis.Amyotrophic Lateral Sclerosis;ALSDrug: IFB-088 50mg/day;Drug: Placebo;Drug: Riluzole 100mg/dayInFlectis BioScienceNULLRecruiting18 YearsN/AAll50Phase 2France;Italy
15NCT05568615
(ClinicalTrials.gov)
October 26, 20222/10/2022Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALSMulticenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)ALSDrug: MT-1186Mitsubishi Tanabe Pharma CorporationNULLRecruiting18 YearsN/AAll30Phase 3Japan
16NCT04998305
(ClinicalTrials.gov)
September 30, 202221/7/2021TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle CrampsA Phase 1/2 Two-center, Double-blind, Randomized, Placebo-controlled Multi-period Crossover (N-of-1) Study to Evaluable the Feasibility, Safety, and Efficacy of TJ-68 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle CrampsAmyotrophic Lateral Sclerosis;Muscle CrampDrug: TJ-68;Drug: PlaceboHiroshi MitsumotoTsumura & Co., Tokyo, JapanRecruiting20 Years70 YearsAll26Phase 1/Phase 2United States
17NCT05286372
(ClinicalTrials.gov)
September 23, 20229/3/2022An Intermediate Size Expanded Access Protocol of AMX0035 for ALSAn Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: AMX0035Amylyx Pharmaceuticals Inc.NULLApproved for marketing18 YearsN/AAllUnited States;Puerto Rico
18NCT05370079
(ClinicalTrials.gov)
September 16, 20226/5/2022Control Cohort CTRL COHControl Cohort CTRL COHParkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid PolyarthritisBiological: Collection of biological sample (blood and/or CSF)Hospices Civils de LyonNULLNot yet recruiting18 YearsN/AAll350N/AFrance
19NCT05281484
(ClinicalTrials.gov)
August 31, 20227/3/2022Intermediate Expanded Access Protocol (EAP) CNMAu8.EAP02A Second Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8Amyotrophic Lateral SclerosisDrug: CNM-Au8Clene NanomedicineNULLAvailable18 YearsN/AAllUnited States
20EUCTR2021-006511-29-DE
(EUCTR)
29/08/202213/06/2022A Phase 2 study of PTC587 in patients with Amyotrophic Lateral SclerosisA PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY, PK, AND BIOMARKER EFFECTS OF PTC857 IN ADULT SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (CARDINALS) - CARDINALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PTC857 oral solution
Product Code: PTC857
INN or Proposed INN: PTC857
Other descriptive name: PTC857
PTC Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 2United States;Czechia;Spain;Ireland;Italy;France;Mexico;Argentina;Belgium;Brazil;Poland;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of;Sweden
21JPRN-jRCT2071220047
26/08/202227/08/2022Formulation Pharmacokinetics Study of EPI-589Formulation Pharmacokinetics Study of EPI-589 (DA350102) Amyotrophic lateral sclerosisSubjects receive a test formulation (containing 1000 mg of EPI-589) or a reference formulation (containing 1000 mg of EPI-589) once orally in period 1 and period 2.Hamatani TatsutoNULLRecruiting>= 20age old< 55age oldMale24Phase 1Japan
22NCT05542576
(ClinicalTrials.gov)
August 24, 20227/9/2022AMDX-2011P Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic ProteinopathyProspective Randomized Open, Blinded Endpoint (PROBE) Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic ProteinopathyParkinson Disease;Amyotrophic Lateral SclerosisDrug: AMDX2011PAmydis Inc.NULLRecruiting18 YearsN/AAll36Phase 1/Phase 2United States
23NCT05442775
(ClinicalTrials.gov)
July 25, 202216/6/2022A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)Amyotrophic Lateral SclerosisDrug: ReldesemtivCytokineticsNULLRecruiting18 YearsN/AAll400Phase 3United States;Australia;Belgium;Canada;Italy;Netherlands;Spain
24EUCTR2021-003900-42-DE
(EUCTR)
15/07/202217/03/2022Continued Efficacy and Safety Study of Oral Edaravone Following Study MT-1186-A02 in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: MT-1186
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Pharma Development America, Inc. (MTDA)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Canada;Germany;Italy;Switzerland;Japan;Korea, Republic of
25NCT05357950
(ClinicalTrials.gov)
May 31, 202227/4/2022A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALSA Phase IIb, Randomized, Multi-Center, Multinational, Prospective, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALSAmyotrophic Lateral Sclerosis;ALSDrug: PrimeC;Drug: PlaceboNeuroSense Therapeutics Ltd.NULLRecruiting18 Years75 YearsAll69Phase 2Israel;United States
26NCT05349721
(ClinicalTrials.gov)
May 15, 202221/4/2022Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALSA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy, Safety, Tolerability, PK, and Biomarker Effects of PTC857 in Adult Subjects With Amyotrophic Lateral Sclerosis (CARDINALS)Amyotrophic Lateral SclerosisDrug: PTC857;Drug: PlaceboPTC TherapeuticsNULLRecruiting18 Years80 YearsAll258Phase 2United States
27NCT05306457
(ClinicalTrials.gov)
May 8, 202221/12/2021CNS10-NPC-GDNF Delivered to the Motor Cortex for ALSHuman Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) Delivered to the Motor Cortex for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: CNS10-NPC-GDNFCedars-Sinai Medical CenterCalifornia Institute for Regenerative Medicine (CIRM)Recruiting18 YearsN/AAll16Phase 1United States
28ChiCTR2200058224
2022-05-012022-04-03The treatment of primidone for bulbar dysfunction in amyotrophic lateral sclerosis: A randomized, double-blind, cross-over controlled clinical trialThe treatment of primidone for bulbar dysfunction in amyotrophic lateral sclerosis: A randomized, double-blind, cross-over controlled clinical trial amyotrophic lateral sclerosisGroup A:phase I: primidone 60 mg/d; Wash-out period: no intervention; phase II: placebo control;Group B:phase I: placebo control; Wash-out period: no intervention; phase II: primidone 60 mg/d;The First People's Hospital of YichangNULLPending18BothGroup A:50;Group B:50;Phase 2China
29EUCTR2021-000250-26-PT
(EUCTR)
29/04/202208/10/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3France;United States;Portugal;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
30NCT05237284
(ClinicalTrials.gov)
April 13, 20222/2/2022Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label ExtensionAmyotrophic Lateral SclerosisDrug: SAR443820;Drug: PlaceboSanofiNULLRecruiting18 Years80 YearsAll261Phase 2United States;Belgium;Canada;China;France;Germany;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom
31EUCTR2021-004156-42-SE
(EUCTR)
12/04/202213/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2France;United States;Canada;Belgium;Spain;Germany;Netherlands;United Kingdom;Italy;Japan;China;Sweden
32EUCTR2020-000579-19-ES
(EUCTR)
04/04/202202/11/2021An international multi-center clinical trial to investigate the efficacy of multiple drug compounds in patients with Amyotrophic Lateral Sclrerosis (ALS).A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS) - MAGNET Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Lithium Carbonate
INN or Proposed INN: Lithium carbonate
Other descriptive name: LITHIUM CARBONATE
Stichting TRICALS FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
171Phase 3Belgium;Spain;Ireland;Australia;Netherlands;United Kingdom;Sweden
33JPRN-jRCT2051220002
03/04/202208/04/2022Phase 1/2 Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS)Phase 1/2 Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)Patients will receive bosutinib once daily, orally, for 24 weeksInoue HaruhisaNULLRecruiting>= 20age old<= 75age oldBoth25Phase 2Japan
34NCT04820478
(ClinicalTrials.gov)
April 1, 202224/3/2021Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS)Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDietary Supplement: Beta Hydroxybutyrate Ester;Dietary Supplement: PlaceboUniversity of UlmNULLRecruiting18 YearsN/AAll76N/AGermany
35NCT04972487
(ClinicalTrials.gov)
March 29, 202215/7/2021Expanded Access Program for Tofersen in Participants With Superoxide Dismutase 1-Amyotropic Lateral SclerosisGlobal Early Access Program to Provide Tofersen To Patients With Amyotrophic Lateral Sclerosis (ALS) Associated With a Mutation in the Superoxide Dismutase 1 (SOD1) GeneSuperoxide Dismutase 1-Amyotropic Lateral SclerosisDrug: TofersenBiogenNULLAvailable18 YearsN/AAllUnited States
36EUCTR2021-004156-42-FR
(EUCTR)
23/03/202220/01/2022Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2United States;France;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom;Japan;Italy;China;Sweden
37EUCTR2021-004156-42-NL
(EUCTR)
10/03/202221/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR443820
INN or Proposed INN: -
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2France;United States;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom;Japan;Italy;China;Sweden
38EUCTR2021-004156-42-ES
(EUCTR)
08/03/202230/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants with amyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR443820
INN or Proposed INN: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom;Japan;Italy;China;Sweden
39NCT05193994
(ClinicalTrials.gov)
February 24, 20226/12/2021Triumeq in Amyotrophic Lateral SclerosisRandomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Dolutegravir, Abacavir and Lamivudine;Drug: PlaceboMacquarie University, AustraliaKing's College London;Stichting TRICALS FoundationRecruiting18 YearsN/AAll390Phase 3Australia
40EUCTR2021-004156-42-BE
(EUCTR)
23/02/202222/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden
41EUCTR2020-003376-40-SE
(EUCTR)
23/02/202229/12/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
42JPRN-jRCT2071210117
23/02/202221/01/2022Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALSA Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis- Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country
- Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to
48 weeks or until the drug is commercially available in that country
Kondo KazuokiNULLRecruiting>= 18age oldNot applicableBoth300Phase 3US;Canada;Germany;Italia;South Korea;Switzerland;Japan
43EUCTR2021-000250-26-PL
(EUCTR)
23/02/202222/11/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
44NCT05136885
(ClinicalTrials.gov)
February 21, 202214/11/2021HEALEY ALS Platform Trial - Regimen E SLS-005 - TrehaloseHEALEY ALS Platform Trial - Regimen E SLS-005 - TrehaloseAmyotrophic Lateral SclerosisDrug: SLS-005;Drug: Matching PlaceboMerit E. Cudkowicz, MDSeelos Therapeutics, Inc.Enrolling by invitation18 YearsN/AAll160Phase 2/Phase 3United States
45EUCTR2019-001862-13-PT
(EUCTR)
18/02/202221/05/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Greece;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
46EUCTR2021-003875-32-IT
(EUCTR)
15/02/202229/12/2021Clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosisA double-blind, placebo-controlled, exploratory randomised clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosis (Study TRIALS) - TRIALS Amyotrophic lateral sclerosis (bulbar-onset)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Icerguastat
Product Code: [IFB-088]
InFlectis BioScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;Italy
47EUCTR2019-001862-13-GR
(EUCTR)
03/02/202226/11/2021Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - Amyotrophic Lateral Sclerosis (ALS) patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Greece;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
48EUCTR2021-002251-11-ES
(EUCTR)
31/01/202208/10/2021A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion.A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: TPN-101
Product Code: TPN-101
INN or Proposed INN: CENSAVUDINE
Transposon Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom
49EUCTR2020-005193-94-BE
(EUCTR)
26/01/202215/10/2021Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: WVE-004
INN or Proposed INN: not yet assigned
Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 1;Phase 2United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden
50EUCTR2020-005193-94-SE
(EUCTR)
26/01/202212/10/2021Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: WVE-004
INN or Proposed INN: not yet assigned
Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 1;Phase 2United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden
51EUCTR2020-004590-51-IT
(EUCTR)
24/01/202207/06/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: nd
Product Code: [BIIB067 (ISIS666853)]
INN or Proposed INN: tofersen
Other descriptive name: BIIB067
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
52EUCTR2020-004040-29-PT
(EUCTR)
14/01/202220/05/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3Portugal;United States;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
53NCT05151471
(ClinicalTrials.gov)
January 11, 202228/11/2021Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALSA Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)ALSDrug: MT-1186;Drug: PlaceboMitsubishi Tanabe Pharma Development America, Inc.NULLRecruiting18 YearsN/AAll300Phase 3United States;Canada;Germany;Japan;Korea, Republic of;Switzerland;United Kingdom
54ChiCTR2100051913
2021-12-312021-10-09Sodium Phenylbutyrate Granules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Lateral Sclerosis: A Multicentre, Randomised, Double-blind, Placebo-controlled Clinical TrialSodium Phenylbutyrate Granules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Lateral Sclerosis: A Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial Amyotrophic lateral sclerosisExperimental group:Sodium phenylbutyrate granules + tauroursodeoxycholic acid capsules;Control group:Sodium phenylbutyrate placebo + tauroursodeoxycholic acid placebo;Peking Union Medical College Hospital, Chinese Academy of Medical SciencesNULLPending1880BothExperimental group:136;Control group:68;N/AChina
55EUCTR2020-005971-11-DE
(EUCTR)
22/12/202111/06/2021A Phase 2a study to evaluate, safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with amyotrophic lateral sclerosis (ALS)A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with familial amyotrophic lateral sclerosis (fALS) and sporadic amyotrophic lateral sclerosis (sALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AP-101
Product Code: AP-101
INN or Proposed INN: Not yet available
Other descriptive name: Anti-(misfolded human superoxide dismutase 1) human IgG1m3 monoclonal antibody
AL-S Pharma, AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2United States;Canada;Germany;Sweden;Korea, Republic of
56NCT05218668
(ClinicalTrials.gov)
December 22, 202123/11/2021Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Fasudil (WP-0512)Woolsey PharmaceuticalsNULLActive, not recruiting18 Years75 YearsAll30Phase 2United States;Australia
57EUCTR2021-000250-26-IT
(EUCTR)
14/12/202118/10/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: AMX0035
Product Code: [AMX0035]
INN or Proposed INN: Sodio phenylbutyrate
INN or Proposed INN: Tauroursodeoxycholic Acid
AMYLYX PHARMACEUTICALS Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
58EUCTR2021-002251-11-DE
(EUCTR)
06/12/202102/08/2021A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion.A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: TPN-101
Product Code: TPN-101
INN or Proposed INN: CENSAVUDINE
Transposon Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;United States;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom
59NCT02478450
(ClinicalTrials.gov)
December 202111/6/2015Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS)A Phase 1/2a Open-Label Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS): Assessment of Localized Therapeutic Activity by Blinded Observation and Lateral Transplantation (ALTA-BOLT)Amyotrophic Lateral SclerosisBiological: Q-CellsQ Therapeutics, Inc.NULLNot yet recruiting18 YearsN/AAll30Phase 1/Phase 2NULL
60NCT05039268
(ClinicalTrials.gov)
November 25, 202123/8/20213K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)A Phase 2 Open Label Trial of 3K3A-APC in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: 3K3A-APC ProteinMacquarie University, AustraliaZZ Biotech, LLCCompleted18 Years75 YearsAll16Phase 2Australia
61EUCTR2020-004040-29-NL
(EUCTR)
25/11/202101/09/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden
62EUCTR2021-000250-26-FR
(EUCTR)
22/11/202125/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;France;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
63NCT04654689
(ClinicalTrials.gov)
November 20, 202113/11/2020Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS PatientsImpact of the Combined Treatment of Curcumin and Resveratrol Liposomed Polyphenols With G04CB02 on the Clinical Improvement of ALS PatientsAmyotrophic Lateral SclerosisDietary Supplement: Liposomed polyphenols resveratrol and curcumin;Other: Placebo for liposomed resveratrol and curcumin;Dietary Supplement: Isocaloric Diet;Drug: G04CB02;Other: Placebo microcrystalline methylcelluloseFundación Universidad Católica de Valencia San Vicente MártirNULLActive, not recruiting18 Years75 YearsAll90Phase 2Spain
64NCT05176093
(ClinicalTrials.gov)
November 14, 20215/11/2021A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral SclerosisA 6-Month Extension Study Following Protocol VMALS-002-2 (A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis)Amyotrophic Lateral SclerosisBiological: Engensis;Other: PlaceboHelixmith Co., Ltd.NULLCompleted18 Years80 YearsAll8Phase 2United States;Korea, Republic of
65NCT05299658
(ClinicalTrials.gov)
November 13, 20218/3/2022An Open-Label Extension for the Phase 2 Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALSAn Open-Label Extension for the Phase 2, Randomised, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALSAmyotrophic Lateral SclerosisDrug: CNMAu8Clene NanomedicineNULLActive, not recruiting30 Years80 YearsAll40Phase 2Australia
66NCT05021536
(ClinicalTrials.gov)
October 28, 202120/8/2021Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis TreatmentA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisOther: Placebo;Drug: AMX0035Amylyx Pharmaceuticals Inc.NULLActive, not recruiting18 YearsN/AAll600Phase 3United States;Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom;Puerto Rico
67EUCTR2021-000250-26-DE
(EUCTR)
27/10/202122/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
68EUCTR2020-003376-40-DE
(EUCTR)
26/10/202116/06/2021A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
69NCT05753852
(ClinicalTrials.gov)
October 25, 202123/2/2023Open Label Extension of TUDCA-ALS StudyOpen Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS StudyAmyotrophic Lateral SclerosisDrug: Tauroursodeoxycholic AcidHumanitas Mirasole SpAUniversity of Ulm;University of Sheffield;University Hospital, Tours;KU Leuven;UMC Utrecht;University of Dublin, Trinity College;Bruschettini S.r.l.;Istituto Superiore di Sanità;Motor Neurone Disease AssociationRecruiting18 YearsN/AAll184Phase 3Belgium;France;Germany;Ireland;Italy;Netherlands;United Kingdom
70NCT05031351
(ClinicalTrials.gov)
October 19, 20215/8/2021NF-?B Inhibition in Amyotrophic Lateral SclerosisNuclear Factor Kappa Beta Inhibition in Patients With Amyotrophic Lateral Sclerosis: A Phase II Randomized Placebo Controlled TrialALSDrug: Withania somnifera;Drug: PlaceboSunnybrook Health Sciences CentreNULLRecruiting18 YearsN/AAll75Phase 2Canada
71NCT05178810
(ClinicalTrials.gov)
October 18, 202116/12/2021Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral SclerosisA Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: FAB122;Drug: PlaceboFerrer Internacional S.A.Julius Clinical;Stichting TRICALS FoundationActive, not recruiting18 Years80 YearsAll300Phase 3Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom
72EUCTR2020-003376-40-IE
(EUCTR)
12/10/202110/06/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
73EUCTR2021-000250-26-ES
(EUCTR)
05/10/202123/07/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: fenilbutirato
INN or Proposed INN: Ursodoxicoltaurina
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: Fenilbutirato
INN or Proposed INN: Ursodoxicoltaurina
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
74EUCTR2020-003376-40-ES
(EUCTR)
05/10/202123/06/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE (ALS Deceleration with ORal Edaravone) study Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Poland;Belgium;Spain;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy
75EUCTR2020-004040-29-ES
(EUCTR)
05/10/202121/06/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
76JPRN-jRCT2061210031
04/10/202127/08/2021EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALSEPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALS - EPIC-ALS Amyotrophic Lateral SclerosisEPI-589 500 mg (2 tablets of EPI-589 250 mg) is orally administered three times a day before meals (at least one hour before breakfast, lunch, and dinner). The treatment period will be from the day after the registration of the treatment period to the end of the examination at 24 weeks of the treatment period.Fujita KojiNULLNot Recruiting>= 18age old<= 79age oldBoth10Phase 2Japan
77NCT04993755
(ClinicalTrials.gov)
October 1, 202119/7/2021A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTDA Phase 2a Study of TPN-101 in Patients With Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated With Hexanucleotide Repeat Expansion in the C9orf72 Gene (C9ORF72 ALS/FTD)Amyotrophic Lateral Sclerosis;Frontotemporal DementiaDrug: TPN-101, 400 mg/day;Drug: PlaceboTransposon Therapeutics, Inc.NULLActive, not recruiting18 YearsN/AAll42Phase 2United States;Belgium;France;Germany;Spain;Netherlands
78EUCTR2020-003376-40-IT
(EUCTR)
28/09/202119/10/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - - Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Edaravone
Product Code: [FAB122]
INN or Proposed INN: Edaravone
Other descriptive name: Norphenazone; methylphenylpyrazolone; norantipyrine; 3-methyl-1-phenyl-4, 5-dihydro-1H-pyrazol-5-one.
Ferrer Internacional S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
79NCT04948645
(ClinicalTrials.gov)
September 22, 202123/6/2021A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral SclerosisA Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of ABBV-CLS-7262 in Subjects With Amyotrophic Lateral Sclerosis Followed by an Active Treatment ExtensionALS;Amyotrophic Lateral SclerosisDrug: ABBV-CLS-7262;Drug: PlaceboCalico Life Sciences LLCAbbVieActive, not recruiting18 Years80 YearsAll31Phase 1United States;Canada
80EUCTR2019-001862-13-DK
(EUCTR)
21/09/202130/06/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Sweden
81EUCTR2020-004040-29-IT
(EUCTR)
20/09/202130/08/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be testedA Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: [CK-2127107]
INN or Proposed INN: reldesemtiv
CYTOKINETICS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
82EUCTR2020-004590-51-DE
(EUCTR)
15/09/202119/03/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Germany;Japan;Sweden;Korea, Republic of
83EUCTR2020-004040-29-SE
(EUCTR)
07/09/202101/06/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
84EUCTR2021-000250-26-NL
(EUCTR)
03/09/202106/07/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
85NCT05053035
(ClinicalTrials.gov)
September 2, 20211/9/2021A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALSA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in C9orf72-Associated Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: AL001;Drug: PlaceboAlector Inc.NULLActive, not recruiting18 YearsN/AAll45Phase 2United States
86EUCTR2021-000250-26-SE
(EUCTR)
26/08/202128/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
87EUCTR2020-003962-38-SE
(EUCTR)
21/08/202105/11/2020A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: RT001
Product Code: RT001
INN or Proposed INN: Not assigned
Other descriptive name: 9-CIS, 12-CIS-11,11-D2-LINOLEIC ACID ETHYL ESTER
Retrotope, Inc.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2Estonia;Netherlands;Sweden
88EUCTR2020-003376-40-PL
(EUCTR)
18/08/202109/07/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;France;Spain;Belgium;Poland;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
89NCT04944784
(ClinicalTrials.gov)
August 16, 202116/6/2021A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Reldesemtiv;Drug: PlaceboCytokineticsNULLRecruiting18 Years80 YearsAll555Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;Switzerland;United Kingdom
90NCT05006352
(ClinicalTrials.gov)
August 11, 20217/8/2021A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral SclerosisA Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, Followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: DNL343;Drug: PlaceboDenali Therapeutics Inc.NULLActive, not recruiting18 Years80 YearsAll30Phase 1United States;Netherlands
91EUCTR2020-003376-40-BE
(EUCTR)
10/08/202108/06/2021A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
92EUCTR2019-003797-10-NL
(EUCTR)
23/07/202109/11/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Netherlands;Germany;Japan
93EUCTR2021-001989-38-ES
(EUCTR)
08/07/202114/06/2021COMPARISON OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE IMPROVEMENT OF PATIENTS WITH ELA WHO ARE BEING TREATED WITH RILUZOLEIMPACT OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE CLINICAL IMPROVEMENT OF PATIENTS WITH ALS TREATED WITH RILUZOLE - IMCRELA Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Dutasterida
Product Name: Dutasterida
INN or Proposed INN: DUTASTERIDE
Other descriptive name: DUTASTERIDE
Facultad de medicina y ciencias de la salud de la Universidad Católica de ValenciaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Spain
94EUCTR2020-000376-38-DE
(EUCTR)
06/07/202119/01/2021A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: MT-1186
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Pharma Development America, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3France;United States;Canada;Germany;Italy;Japan
95EUCTR2020-004040-29-IE
(EUCTR)
02/07/202109/04/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
96NCT04788745
(ClinicalTrials.gov)
June 29, 20212/3/2021Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)Targeting Metabolic Flexibility in ALS (MetFlex); Safety and Tolerability of Trimetazidine for the Treatment of ALSAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: Trimetazidine DihydrochlorideThe University of QueenslandFightMND;UMC Utrecht;King's College London;Julius Clinical, The NetherlandsRecruiting18 Years75 YearsAll36Phase 2Australia;Netherlands;United Kingdom
97NCT04931862
(ClinicalTrials.gov)
June 28, 202111/6/2021Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)ALS;FTDDrug: WVE-004;Drug: PlaceboWave Life Sciences Ltd.NULLActive, not recruiting18 Years80 YearsAll35Phase 1/Phase 2Australia;Belgium;Canada;Ireland;Netherlands;New Zealand;Sweden;United Kingdom
98EUCTR2016-003225-41-ES
(EUCTR)
28/06/202114/06/2021Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand
99EUCTR2020-000579-19-NL
(EUCTR)
25/06/202129/03/2021An international multi-center clinical trial to investigate the efficacy of multiple drug compounds in patients with Amyotrophic Lateral Sclrerosis (ALS).A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS) - MAGNET Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Lithium Carbonate
INN or Proposed INN: Lithium carbonate
Other descriptive name: LITHIUM CARBONATE
Stichting TRICALS FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
171Phase 3Spain;Belgium;Ireland;Australia;Netherlands;United Kingdom;Sweden
100EUCTR2020-005069-15-NL
(EUCTR)
23/06/202114/04/2021LIGHTHOUSE 2RANDOMISED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 3 TRIAL OF TRIUMEQ IN AMYOTROPHIC LATERAL SCLEROSIS - Lighthouse 2 Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Triumeq
Product Name: Triumeq
INN or Proposed INN: Dolutegravir
INN or Proposed INN: Abacavir
INN or Proposed INN: Lamivudine
Stichting TRICALS FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Phase 3Australia;Netherlands;United Kingdom
101NCT04768972
(ClinicalTrials.gov)
June 14, 202122/2/2021A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients With Fused in Sarcoma Mutations (FUS-ALS)Amyotrophic Lateral SclerosisDrug: ION363;Drug: PlaceboIonis Pharmaceuticals, Inc.NULLRecruiting12 YearsN/AAll77Phase 3United States;Belgium;Canada;Korea, Republic of;Netherlands;United Kingdom;Australia
102EUCTR2020-004590-51-FR
(EUCTR)
03/06/202101/04/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
103EUCTR2020-004590-51-ES
(EUCTR)
17/05/202101/09/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
104NCT04856982
(ClinicalTrials.gov)
May 17, 202120/4/2021A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationA Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationAmyotrophic Lateral Sclerosis Associated With a SOD1 Gene MutationDrug: BIIB067 (Tofersen);Drug: PlaceboBiogenNULLRecruiting18 YearsN/AAll150Phase 3United States;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain;Sweden;United Kingdom;Russian Federation
105JPRN-jRCT2071210023
17/05/202117/05/2021Clinical Pharmacology Study of EPI-589Clinical Pharmacology Study of EPI-589 (DA350101) Amyotrophic lateral sclerosisCohort 1 : multiple oral administration, 750 mg, three times a day, EPI-589 or placebo
Cohort 2 : multiple oral administration, 1000 mg, three times a day, EPI-589 or placebo
Cohort 3 : multiple oral administration, 1250 mg, three times a day, EPI-589 or placebo
Cohort 4 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo
Cohort 5 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo
Hamatani TatsutoNULLRecruiting>= 20age old<= 55age oldMale40Phase 1Japan
106EUCTR2020-005018-17-NL
(EUCTR)
14/05/202108/04/2021Safety and tolerability of Trimetazidine in amyotrophic lateral sclerosis (ALS)Targeting metabolic flexibility in ALS (MetFlex); Safety and tolerability of Trimetazidine for the treatment of ALS - MetFlex Patients suffering from amyotrophic lateral sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Vastarel
Product Name: Trimetazidine
Product Code: 201600930
The University of QueenslandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2Australia;Netherlands
107EUCTR2019-003797-10-CZ
(EUCTR)
13/05/202127/10/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan
108EUCTR2019-004256-11-DE
(EUCTR)
11/05/202117/11/2020An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: MT-1186
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Pharma Development America, Inc. (MTDA)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of
109NCT04849065
(ClinicalTrials.gov)
May 1, 202115/4/2021Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral SclerosisClinical Trial in Phase II of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.ALS (Amyotrophic Lateral Sclerosis)Drug: MNC (Mononuclear cells);Drug: Placebo / SalineFundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaNULLNot yet recruiting18 Years70 YearsAll100Phase 2Spain
110NCT03843710
(ClinicalTrials.gov)
April 30, 202114/2/201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Gold NanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterNot yet recruiting35 Years75 YearsAll24Phase 2United States
111EUCTR2021-000325-26-FR
(EUCTR)
29/04/202119/02/2021Phase 2 safety and tolerability study using ANX005 for ALSPhase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Scelrosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: IMMUNOGLOBULIN G
Annexon BiosciencesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;France;Canada
112EUCTR2019-003797-10-IE
(EUCTR)
06/04/202103/09/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Australia;Netherlands;Germany;Japan
113NCT04681118
(ClinicalTrials.gov)
March 24, 202118/12/2020Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALSIntermediate-size Patient Population Expanded Access Protocol: Repeated Administration of Nurown® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisBiological: NurOwn (MSC-NTF cells)Brainstorm-Cell TherapeuticsNULLNo longer available18 Years63 YearsAllUnited States
114NCT04745299
(ClinicalTrials.gov)
March 23, 202127/1/2021Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALSA Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lenzumestrocel(Neuronata-R® Inj.) in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Lenzumestrocel;Drug: Riluzole;Drug: Placebo ComparatorCorestem, Inc.NULLRecruiting25 Years75 YearsAll115Phase 3Korea, Republic of
115EUCTR2019-004256-11-IT
(EUCTR)
22/03/202124/05/2021An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - N/A Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: [MT-1186]
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of
116EUCTR2020-000376-38-IT
(EUCTR)
22/03/202124/05/2021A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - MT-1186-A03 Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: [MT-1186]
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Canada;Germany;Japan;Italy
117NCT04762589
(ClinicalTrials.gov)
March 10, 202117/2/2021RT001 in Amyotrophic Lateral SclerosisA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: RT001;Drug: PlaceboRetrotope, Inc.NULLRecruiting20 Years75 YearsAll40Phase 2Estonia;Latvia;Netherlands;Sweden
118ITMCTR2100004558
2021-03-012021-03-09A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS).A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS). Amyotrophic lateral sclerosisexperimental group:Huoling Shengji Keli granules 1 bag + riluzole tablets simulant 1 tablet each time, Bid, oral;control group:Huoling Shengji Keli granules simulant 1 bag + riluzole tablets 1 tablet each time, Bid, oral;Peking University Third HospitalNULLRecruiting4570Bothexperimental group:72;control group:72;Phase 2China
119ChiCTR2100044085
2021-03-012021-03-09A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS).A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS). Amyotrophic lateral sclerosisexperimental group:Huoling Shengji Keli granules 1 bag + riluzole tablets simulant 1 tablet each time, Bid, oral;control group:Huoling Shengji Keli granules simulant 1 bag + riluzole tablets 1 tablet each time, Bid, oral;Peking University Third HospitalNULLRecruiting4570Bothexperimental group:72;control group:72;Phase 2China
120JPRN-jRCT2031200361
26/02/202115/02/2021Comparative Bioavailability study of Oral Edaravone Administered orally and via a Nasogastric TubeA Phase I, Randomized, Open-Label, Crossover-Design, Single-Dose Study to Investigate the Safety, Tolerability and Comparative Bioavailability of Oral Edaravone Administered orally and via a Nasogastric Tube (NGT) in Healthy Adult Subjects Amyotrophic Lateral SclerosisSubjects will receive the edaravone oral suspension orally. And, subjects will receive the edaravone oral suspension via a NGT.Kondo KazuokiNULLComplete>= 20age old<= 45age oldBoth36Phase 1Japan
121EUCTR2019-003797-10-DE
(EUCTR)
18/02/202112/10/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Poland;Belgium;Australia;Germany;Netherlands;Japan
122EUCTR2020-003962-38-NL
(EUCTR)
18/02/202118/01/2021A DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY OF RT001 TREATMENT, FOR PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: RT001
Product Code: RT001
INN or Proposed INN: Not assigned
Other descriptive name: 9-CIS, 12-CIS-11,11-D2-LINOLEIC ACID ETHYL ESTER
Retrotope, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2Estonia;Netherlands;Sweden
123NCT04632225
(ClinicalTrials.gov)
February 9, 202129/10/2020Safety of Engensis in Participants With Amyotrophic Lateral SclerosisA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Engensis;Other: PlaceboHelixmith Co., Ltd.NULLCompleted18 Years80 YearsAll18Phase 2United States;Korea, Republic of
124EUCTR2019-001862-13-IT
(EUCTR)
03/02/202106/11/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - non applicable Patients suffering from Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Masitinib mesilate
Product Code: [AB1010]
INN or Proposed INN: Masitinib mesilate
Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003
Product Name: Masitinib mesilate
Product Code: [AB1010]
INN or Proposed INN: Masitinib mesilate
Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003
AB SCIENCENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
125EUCTR2019-003797-10-IT
(EUCTR)
03/02/202128/07/2021A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter studyto evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) - MERIDIAN Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplam
Product Code: [APL-2]
Other descriptive name: N/A
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan
126EUCTR2019-001862-13-NO
(EUCTR)
03/02/202120/11/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3Portugal;United States;Slovenia;Spain;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
127EUCTR2020-003962-38-EE
(EUCTR)
02/02/202103/11/2020A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: RT001
Product Code: RT001
INN or Proposed INN: Not assigned
Other descriptive name: 9-CIS, 12-CIS-11,11-D2-LINOLEIC ACID ETHYL ESTER
Retrotope, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2Estonia;Netherlands;Sweden
128NCT03651349
(ClinicalTrials.gov)
February 1, 202126/8/2018To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy VolunteersA Phase I Study to Determine the Maximum Tolerated Dose (MTD) of HK-001 and to Evaluate Its Pharmacokinetic Profile in Healthy VolunteersAmyotrophic Lateral SclerosisDrug: HK-001;Drug: Placebo controlEverfront Biotech Co., Ltd.NULLActive, not recruiting20 YearsN/AAll56Phase 1Taiwan
129JPRN-jRCT2031200301
25/01/202115/01/2021Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALSA Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral SclerosisGroup 1: Oral edaravone administered once daily for 28 days, in Cycles 1 through 12
Group 2: Oral edaravone administered for 14 days, followed by placebo for 14 days in Cycle 1. Subsequently, repeat oral edaravone administered for 10 days followed by placebo for 18 days (regimen denoted as on/off) in Cycles 2 through 12
Kondo KazuokiNULLRecruiting>= 18age old<= 75age oldBoth380Phase 3Korea;Germany;United States of America;Canada;France;Switzerland;Italy;Japan
130NCT04575727
(ClinicalTrials.gov)
January 8, 202129/9/2020Exploratory Evaluation of [11C]MPC6827Exploratory Evaluation of [11C]MPC6827 Pharmacokinetics With Positron Emission Tomography (PET)Neurodegenerative Diseases;Alzheimer Disease;Amyotrophic Lateral SclerosisDrug: [11C]MPC6827Columbia UniversityNULLRecruiting18 YearsN/AAll40Early Phase 1United States
131NCT04390386
(ClinicalTrials.gov)
January 1, 202113/5/2020Controlled Study of IC14 for Treatment of ALSAmyotrophic Lateral Sclerosis Trial: A Randomized, Double-Blind, Placebo-Controlled Study: IC14, a Monoclonal Antibody Against CD14Amyotrophic Lateral SclerosisBiological: IC14;Other: PlaceboImplicit BioscienceNULLWithdrawn18 Years70 YearsAll0Phase 2United States
132ChiCTR2000028960
2021-01-012020-01-09Exploratory study of low-intensity ultrasound in the disease progression of amyotrophic lateral sclerosisExploratory study of low-intensity ultrasound in the disease progression of amyotrophic lateral sclerosis Amyotrophic lateral sclerosisexperimental group:wearable low-intensity ultrasound and Riluzole;control group:ineffective ultrasound and Riluzole;University Affiliated Sixth People's HospitalNULLPending1870Bothexperimental group:20;control group:20;China
133JPRN-jRCT2041200084
23/12/202024/12/2020Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral SclerosisOral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free periodKondo KazuokiNULLNot Recruiting>= 18age oldNot applicableBoth140Phase 3United States of America;Canada;Germany;France;Italy;Japan
134NCT04615923
(ClinicalTrials.gov)
December 18, 202029/10/2020HEALEY ALS Platform Trial - Regimen D PridopidineHEALEY ALS Platform Trial - Regimen D PridopidineAmyotrophic Lateral SclerosisDrug: Pridopidine;Drug: Matching PlaceboMerit E. Cudkowicz, MDPrilenia TherapeuticsActive, not recruiting18 YearsN/AAll163Phase 2/Phase 3United States
135EUCTR2016-003225-41-DK
(EUCTR)
16/12/202009/06/2020Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Denmark;Australia;Germany;Japan;New Zealand
136NCT04220190
(ClinicalTrials.gov)
December 15, 20203/1/2020RAPA-501 Therapy for ALSPhase I Trial of Autologous Hybrid TREG/Th2 Cell (RAPA-501) Therapy for Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: RAPA-501 Autologous T cellsRapa Therapeutics LLCMassachusetts General Hospital;Hackensack Meridian HealthRecruiting18 YearsN/AAll18Phase 1/Phase 2United States
137NCT04651855
(ClinicalTrials.gov)
December 2, 202030/9/2020The Evaluation of the Effect of Mesenchymal Stem Cells on the Immune System of Patients With ALSThe Evaluation of the Effect of Wharton's Jelly Mesenchymal Stem Cells (WJMSCs) on the Immune System of Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Mesenchymal stem cells isolated from Wharton's jellyPolski Bank Komorek Macierzystych JSC (PBKM)National Center for Research and Development, PolandActive, not recruiting18 YearsN/AAll20Phase 1/Phase 2Poland
138EUCTR2016-003225-41-PL
(EUCTR)
01/12/202022/07/2020Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: -
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 3United States;European Union;Canada;Argentina;Belgium;Poland;Denmark;Australia;Germany;United Kingdom;Japan;Korea, Republic of
139EUCTR2019-001862-13-PL
(EUCTR)
01/12/202009/07/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
140NCT04514952
(ClinicalTrials.gov)
November 23, 202012/8/2020Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral SclerosisIndividual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: HB-adMSCsHope Biosciences Stem Cell Research FoundationHope BiosciencesNo longer availableN/AN/AAllUnited States
141NCT04516096
(ClinicalTrials.gov)
November 22, 20209/8/2020A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS)AMX0035 for Amyotrophic Lateral Sclerosis - Compassionate Use ProtocolAmyotrophic Lateral SclerosisDrug: AMX0035Amylyx Pharmaceuticals Inc.NULLActive, not recruiting18 YearsN/AAll40Phase 2/Phase 3United States
142EUCTR2015-004098-33-PL
(EUCTR)
18/11/202010/07/2020An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 3United States;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Australia;Denmark;Germany;Japan;Korea, Republic of;Sweden
143NCT04569084
(ClinicalTrials.gov)
November 13, 202023/9/2020Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALSA Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)ALSDrug: MT-1186;Drug: PlaceboMitsubishi Tanabe Pharma Development America, Inc.NULLActive, not recruiting18 Years75 YearsAll380Phase 3United States;Canada;Germany;Italy;Japan;Korea, Republic of;Switzerland
144NCT04391361
(ClinicalTrials.gov)
November 1, 202013/5/2020The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALSThe Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;Respiratory Function;ScopolamineDrug: Scopolamine, atropine, edaravone and dexmedetomidine;Drug: EdaravoneRuijin HospitalNULLNot yet recruiting30 Years65 YearsAll30Phase 2China
145NCT04577404
(ClinicalTrials.gov)
October 29, 202030/9/2020Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: MT-1186Mitsubishi Tanabe Pharma Development America, Inc.NULLActive, not recruiting18 YearsN/AAll140Phase 3United States;Canada;France;Germany;Italy;Japan
146EUCTR2019-001862-13-SE
(EUCTR)
14/10/202023/03/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3Portugal;United States;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
147NCT04562831
(ClinicalTrials.gov)
October 7, 202010/9/2020The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS StudyAmyotrophic Lateral SclerosisDietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene)Haukeland University HospitalElysium HealthRecruiting35 YearsN/AAll380N/ANorway
148ChiCTR2000035988
2020-10-012020-08-21Exploratory study of wearable low-intensity ultrasound in the disease progression of Amyotrophic lateral sclerosisExploratory study of wearable low-intensity ultrasound in the disease progression of Amyotrophic lateral sclerosis Amyotrophic lateral sclerosisexperimental group:wearable low-intenstiy ultrasound + riluzole;control group:invalid ultrasound + riluzole;Shanghai Sixth People's HospitalNULLPending1870Bothexperimental group:25;control group:25;China
149NCT03127267
(ClinicalTrials.gov)
October 1, 202013/4/2017Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS PatientsA Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Masitinib (6.0);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (4.5)AB ScienceNULLRecruiting18 Years81 YearsAll495Phase 3United States;Germany;Canada
150NCT04579666
(ClinicalTrials.gov)
September 30, 202022/9/2020MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: Pegcetacoplan (APL-2);Other: PlaceboApellis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll249Phase 2United States;Australia;Belgium;Czechia;France;Germany;Ireland;Italy;Japan;Netherlands;Poland;Spain;Ukraine;United Kingdom
151NCT04494256
(ClinicalTrials.gov)
September 28, 202030/7/2020A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic MutationA Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the Ataxin-2 GeneAmyotrophic Lateral SclerosisDrug: BIIB105;Drug: PlaceboBiogenNULLRecruiting18 YearsN/AAll98Phase 1/Phase 2United States;Canada;Italy;Netherlands
152NCT04557410
(ClinicalTrials.gov)
September 23, 202031/5/2020Open Label Study: Treatment of ALS Fatigue With PolyMVAOpen Label Study: Treatment of ALS Fatigue With PolyMVAAmyotrophic Lateral SclerosisDrug: PolyMVAUniversity of Missouri-ColumbiaBand of Hope FoundationCompletedN/AN/AAll12Phase 1United States
153EUCTR2019-001862-13-ES
(EUCTR)
15/09/202012/06/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
154EUCTR2019-004619-30-IE
(EUCTR)
14/09/202003/02/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of
155NCT04428775
(ClinicalTrials.gov)
September 8, 20203/6/2020A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS DiseaseA Phase IIa, Randomized, Open-label, Multi-Center, Multi-Dose Study to Evaluate the Effects of ALZT-OP1a in Subjects With Mild-Moderate Stage Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: ALZT-OP1a (cromolyn)AZTherapies, Inc.NULLTerminated18 Years75 YearsAll12Phase 2United States
156NCT04518540
(ClinicalTrials.gov)
September 1, 20205/8/2020Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral SclerosisRandomized, Parallel Safety and Efficacy Study of Lipoic Acid in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: lipoic acid group;Drug: control groupSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting20 Years75 YearsAll150N/AChina
157NCT04499963
(ClinicalTrials.gov)
August 28, 202031/7/2020Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)An Open-label, Single-center, 6-month Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Theracurmin HPRichard Bedlack, M.D., Ph.D.NULLCompleted18 YearsN/AAll68Phase 2United States
158EUCTR2019-004619-30-DK
(EUCTR)
12/08/202003/03/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
354Phase 3France;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden;United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy
159EUCTR2019-004619-30-DE
(EUCTR)
07/08/202011/02/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
160EUCTR2018-004171-12-PL
(EUCTR)
22/07/202005/09/2019The evaluation of the effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the immune system of patients with Amyotrophic Lateral Sclerosis (ALS)The evaluation of the effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the immune system of patients with Amyotrophic Lateral Sclerosis (ALS) - ALSTEM Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: FamC-1
INN or Proposed INN: WHARTON’S JELLY-DERIVED MESENCHYMAL STEM CELLS
Other descriptive name: WHARTON’S JELLY-DERIVED MESENCHYMAL STEM CELLS
Polski Bank Komórek Macierzystych JSC (PBKM)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Poland
161NCT04297683
(ClinicalTrials.gov)
July 14, 20203/3/2020HEALEY ALS Platform Trial - Master ProtocolHEALEY ALS Platform TrialAmyotrophic Lateral SclerosisDrug: Zilucoplan;Drug: Verdiperstat;Drug: CNM-Au8;Drug: Pridopidine;Drug: SLS-005 TrehaloseMerit E. Cudkowicz, MDMassachusetts General HospitalRecruiting18 YearsN/AAll800Phase 2/Phase 3United States
162EUCTR2019-004619-30-IT
(EUCTR)
03/07/202017/01/2022An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: [ALXN1210]
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: RAVULIZUMAB
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of
163NCT03766321
(ClinicalTrials.gov)
July 1, 202030/11/2018Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis PatientsInterplay Between Gut Microbiota and Adaptive Immunity in Amyotrophic Lateral Sclerosis: a Clinical TrialAmyotrophic Lateral SclerosisBiological: Fecal microbiota transplantation;Biological: PlaceboAzienda Ospedaliero-Universitaria di ModenaUniversity of Modena and Reggio Emilia;Catholic University of the Sacred Heart;Campus Bio-Medico University;Azienda Ospedaliero-Universitaria Careggi;Azienda Ospedaliera di Perugia;University of Chieti;University of FlorenceActive, not recruiting18 Years70 YearsAll42N/AItaly
164EUCTR2019-004619-30-SE
(EUCTR)
22/06/202004/02/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden
165NCT04950933
(ClinicalTrials.gov)
June 1, 202027/6/2021The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji GranulesA Multi-center, Randomized, Double-blind, Positives Parallel Controlled, Phase ? Clinical Trial to Evaluate the Efficacy and Safety of Huollingshengji Granules in the Treatment of Amyotrophic Lateral Sclerosis (Spleen qi Deficiency, Kidney Yang Deficiency Syndrome)Amyotrophic Lateral SclerosisDrug: Huolingshengji Granules;Drug: Riluzole tabletPeking University Third HospitalThe Second Hospital of Hebei Medical UniversityRecruiting45 Years70 YearsAll144Phase 2/Phase 3China
166NCT04057898
(ClinicalTrials.gov)
May 28, 20206/8/2019Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALSA Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: MN-166;Drug: placeboMediciNovaNULLRecruiting18 Years80 YearsAll230Phase 2/Phase 3United States;Canada
167EUCTR2019-004619-30-GB
(EUCTR)
26/05/202007/02/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: Ultomiris
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
354Phase 3United States;Spain;Ireland;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of
168EUCTR2019-004619-30-FR
(EUCTR)
20/05/202020/08/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of
169EUCTR2019-004619-30-ES
(EUCTR)
14/05/202006/03/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
354Phase 3France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;Japan;Sweden;Korea, Republic of
170EUCTR2019-002108-41-DE
(EUCTR)
06/05/202017/01/2020A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: MT-1186
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Pharma Development America, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Canada;Germany;Italy;Japan
171NCT04288856
(ClinicalTrials.gov)
April 28, 202026/2/2020Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: BIIB078BiogenNULLTerminated18 YearsN/AAll75Phase 1United States;Canada;Netherlands;Switzerland;United Kingdom
172EUCTR2020-000352-36-DK
(EUCTR)
27/04/202013/02/2020Metabolic MRI of amyotrophic lateral sclerosis and mini strokesMRI of neurometabolic impairment in ALS and TIA using hyperpolarized pyruvate Amyotrophic lateral sclerosisTransient ischemic attack
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Product Name: Hyperpolarized [1-13C]pyruvate
INN or Proposed INN: SODIUM PYRUVATE
Other descriptive name: SODIUM PYRUVATE
Christoffer LaustsenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2Denmark
173EUCTR2019-002108-41-IT
(EUCTR)
24/04/202017/06/2021A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - n/a Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: [MT-1186]
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3France;United States;Canada;Germany;Japan;Italy
174EUCTR2019-004619-30-NL
(EUCTR)
23/04/202009/03/2020An Efficacy and Safety Study of Ravulizumab in ALS PatientsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients Amyotrophic Lateral Sclerosis (ALS), motor neuron disease
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
354Phase 3United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of
175NCT04326283
(ClinicalTrials.gov)
April 2, 202024/3/2020Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Trametinib (0.5 mg);Drug: Trametinib (1 mg);Drug: Riluzole (100 mg)Genuv Inc.NULLRecruiting19 Years75 YearsAll30Phase 1/Phase 2Korea, Republic of
176NCT04248465
(ClinicalTrials.gov)
March 30, 202027/1/2020An Efficacy and Safety Study of Ravulizumab in ALS ParticipantsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;ALSDrug: Placebo;Biological: RavulizumabAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll382Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Japan;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom
177EUCTR2015-004098-33-DK
(EUCTR)
23/03/202002/03/2020An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 1;Phase 2;Phase 3France;United States;Canada;Poland;Belgium;Australia;Denmark;Germany;United Kingdom;Italy;Japan;Sweden
178NCT04313166
(ClinicalTrials.gov)
March 19, 202015/3/2020Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001Amyotrophic Lateral SclerosisDrug: Cu(II)ATSMCollaborative Medicinal Development Pty LimitedNULLCompleted18 Years75 YearsAll55Phase 2Australia
179EUCTR2019-001862-13-SI
(EUCTR)
12/03/202019/02/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
180EUCTR2019-003549-14-HU
(EUCTR)
11/03/202013/01/2020A Clinical Trial To Evaluate The Efficacy And Safety Of Mn-166 (Ibudilast) In Subjects With Amyotrophic Lateral Sclerosis(Lou Gehrig's disease)A PHASE 2B/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12 MONTH CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MN-166 (IBUDILAST) FOLLOWED BY AN OPEN-LABEL EXTENSION IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS - COMBAT-ALS Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ibudilast
Product Code: MN-166
INN or Proposed INN: IBUDILAST
MediciNova, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 2;Phase 3United States;Hungary;Greece;Poland;Spain;Germany;Italy
181NCT04302870
(ClinicalTrials.gov)
February 27, 20204/3/2020Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised TrialMotor Neurone Disease - Systematic Multi-Arm Adaptive Randomised TrialMotor Neuron Disease, Amyotrophic Lateral SclerosisDrug: Memantine Hydrochloride Oral Solution;Drug: Trazodone Hydrochloride oral solution;Drug: Placebo oral solutionUniversity of EdinburghUniversity College, London;University of Warwick;NHS LothianRecruiting18 YearsN/AAll750Phase 2/Phase 3United Kingdom
182NCT04245709
(ClinicalTrials.gov)
February 10, 202026/1/2020Clenbuterol on Motor Function in Individuals With Amyotrophic Lateral SclerosisA Clinical Investigation of the Safety and Efficacy of Clenbuterol on Motor Function in Individuals With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: ClenbuterolDwight Koeberl, M.D., Ph.D.NULLCompleted18 YearsN/AAll25Phase 2United States
183EUCTR2016-003225-41-IT
(EUCTR)
10/02/202015/06/2021Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - na Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: nd
Product Code: [BIIB067 (ISIS666853)]
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
182Phase 3United States;European Union;Canada;Spain;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Japan;Italy
184EUCTR2018-004180-31-FR
(EUCTR)
31/01/202007/11/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
185NCT04254913
(ClinicalTrials.gov)
January 24, 202023/1/2020Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With GastrostomyClinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With GastrostomyJapanese Patients With ALSDrug: MT-1186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years80 YearsAll6Phase 1Japan
186NCT04220021
(ClinicalTrials.gov)
January 10, 20203/1/2020Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTDA Single-Center, Open Label Study to Assess the Safety and Tolerability of Metformin in Subjects With C9orf72 Amyotrophic Lateral Sclerosis Over 24 Weeks of TreatmentC9orf72 Amyotrophic Lateral Sclerosis (ALS);Frontotemporal DementiaDrug: MetforminUniversity of FloridaNULLRecruiting18 Years80 YearsAll18Phase 2United States
187NCT04952155
(ClinicalTrials.gov)
January 1, 202027/6/2021Low Dose IL-2 in the Treatment of Immune-associated ALS SyndromeA Single-center, Open-label Clinical Study to Evaluate the Efficacy and Safety of Low-dose IL-2 in the Treatment of Immune-associated ALS SyndromeAmyotrophic Lateral SclerosisDrug: IL-2Peking University Third HospitalNULLRecruiting18 Years70 YearsAll13Phase 2China
188EUCTR2017-003676-31-FR
(EUCTR)
31/12/201925/04/2018Inhibition of Rho Kinase (ROCK) with Fasudil as disease-modifying treatment for ALSInhibition of Rho Kinase (ROCK) with Fasudil as disease-modifying treatment for ALS Amyotrophic lateral sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Eril®
INN or Proposed INN: FASUDIL HYDROCHLORIDE
Other descriptive name: FASUDIL HYDROCHLORIDE
Georg-August-Universität GöttingenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2France;Germany;Switzerland
189NCT04066244
(ClinicalTrials.gov)
December 30, 201921/8/2019Study of Safety and of the Mechanism of BLZ945 in ALS PatientsAn Open-label, Adaptive Design Study in Patients With Amyotrophic Lateral Sclerosis (ALS) to Characterize Safety, Tolerability and Brain Microglia Response, as Measured by TSPO Binding, Following Multiple Doses of BLZ945 Using Positron Emission Tomography (PET) With the Radioligand [11C]-PBR28Amyotrophic Lateral SclerosisDrug: BLZ945Novartis PharmaceuticalsNULLRecruiting18 YearsN/AAll56Phase 2United States;Finland;Sweden
190NCT04098406
(ClinicalTrials.gov)
December 19, 201919/9/2019Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS.Amyotrophic Lateral SclerosisDrug: CNM-Au8;Drug: PlaceboClene NanomedicineClene Australia Pty LtdCompleted30 Years80 YearsAll45Phase 2Australia
191EUCTR2018-004180-31-IE
(EUCTR)
16/12/201902/08/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
192NCT04090684
(ClinicalTrials.gov)
December 9, 201929/8/2019Ciprofloxacin/Celecoxib Combination in Patients With ALSOpen Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALSALS (Amyotrophic Lateral Sclerosis)Drug: Fixed dose combination Ciprofloxacin/CelecoxibNeuroSense Therapeutics Ltd.NULLCompleted18 Years75 YearsAll10Phase 1United States
193NCT03377309
(ClinicalTrials.gov)
December 1, 201914/12/2017Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis PatientsSafety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis PatientsAmyotrophic Lateral SclerosisDrug: FycompaAmerican University of Beirut Medical CenterNULLTerminated18 Years80 YearsAll6Phase 2Lebanon
194NCT04172792
(ClinicalTrials.gov)
November 26, 201919/11/2019Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDietary Supplement: high-caloric fatty diet;Dietary Supplement: ultra-high-caloric fatty diet;Dietary Supplement: ultra-high-caloric carbohydrate-rich dietAlbert Christian Ludolph, Prof.Nutritia GmbH, 91052 Erlangen, GermanyCompleted18 YearsN/AAll64Phase 1Germany
195NCT04165850
(ClinicalTrials.gov)
November 25, 201913/11/2019Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALSOpen Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALSAmyotrophic Lateral Sclerosis;ALSDrug: Fixed dose combination Ciprofloxacin/CelecoxibNeuroSense Therapeutics Ltd.NULLCompleted18 Years75 YearsAll16Phase 2Israel
196EUCTR2018-002722-22-NL
(EUCTR)
21/11/201906/06/2019Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TUDCABIL
INN or Proposed INN: tauroursodeoxycholic acid
Other descriptive name: TAUROURSODEOXYCHOLIC ACID
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Belgium;Germany;Netherlands;Italy;United Kingdom
197EUCTR2019-000826-22-FI
(EUCTR)
05/11/201918/09/2019Study of safety and of the mechanism of BLZ945 in amyotrophic lateral sclerosis (ALS) patients.An open-label, adaptive design study in patients with amyotrophic lateral sclerosis (ALS) to characterize safety, tolerability and brain microglia response, as measured by TSPO binding, following multiple doses of BLZ945 using positron emission tomography (PET) with the radioligand [11C]-PBR28 Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BLZ945
INN or Proposed INN: Not yet defined
Other descriptive name: BLZ945
Product Code: BLZ945
INN or Proposed INN: Not yet defined
Other descriptive name: BLZ945
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2United States;Finland;Sweden
198EUCTR2019-002302-46-ES
(EUCTR)
23/10/201909/08/2019Phase II clinical trial of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosisPhase II clinical trial of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: autologous adult bone marrow mononuclear cells (BM-MNC) unexpanded
INN or Proposed INN: autologous adult bone marrow mononuclear cells unexpanded
Other descriptive name: autologous adult bone marrow mononuclear cells unexpanded
Fundación para la Formación e Investigación Sanitarias de la Región de MurciaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain
199NCT04259255
(ClinicalTrials.gov)
October 21, 201927/1/2020Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)Amyotrophic Lateral Sclerosis;ALSDrug: Edaravone (Radicava®/Radicava ORS®)Mitsubishi Tanabe Pharma America Inc.Massachusetts General HospitalRecruiting18 YearsN/AAll300United States;Canada
200NCT04309604
(ClinicalTrials.gov)
October 18, 201912/3/2020IC14 for ALS Patients Expanded AccessIC14 for ALS Patients Expanded AccessAmyotrophic Lateral SclerosisBiological: IC14Implicit BioscienceMassachusetts General HospitalNo longer available18 YearsN/AAllUnited States
201NCT03981536
(ClinicalTrials.gov)
October 10, 201930/5/2019A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)A Multicenter, Open Label, Single-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: AP-101AL-S PharmaNULLActive, not recruiting18 YearsN/AAll18Phase 1Canada
202ChiCTR2000035966
2019-10-102020-08-20Clinical efficacy of expanded autologous regulatory T cells infusion in amyotrophic lateral sclerosisClinical efficacy and safety of expanded autologous peripheral blood mononuclear cells in amyotrophic lateral sclerosis Amyotrophic lateral sclerosisCase series:T cell therapy + Herb Qu + Interleukin-2;Nanjing Hospital Affiliated to Nanjing University of traditional Chinese MedicineNULLRecruitingBothCase series:30;China
203EUCTR2019-000374-39-DE
(EUCTR)
04/10/201928/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
204EUCTR2018-004180-31-NL
(EUCTR)
02/10/201923/07/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
205NCT04082832
(ClinicalTrials.gov)
September 30, 20192/9/2019CuATSM Compared With Placebo for Treatment of ALS/MNDA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Cu(II)ATSM in Patients With Amyotrophic Lateral Sclerosis/Motor Neuron DiseaseAmyotrophic Lateral SclerosisDrug: Cu(II)ATSM;Drug: PlacebosCollaborative Medicinal Development Pty LimitedNULLRecruiting18 Years75 YearsAll80Phase 2/Phase 3Australia
206EUCTR2019-000374-39-SE
(EUCTR)
26/09/201916/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
207NCT03836716
(ClinicalTrials.gov)
September 19, 20197/2/2019Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension TrialOpen Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 TrialAmyotrophic Lateral SclerosisDrug: ArimoclomolOrphazymeNULLTerminated18 YearsN/AAll120Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;Switzerland
208EUCTR2019-000826-22-SE
(EUCTR)
17/09/201902/08/2019Study of safety and of the mechanism of BLZ945 in amyotrophic lateral sclerosis (ALS) patients.An open-label, adaptive design study in patients with amyotrophic lateral sclerosis (ALS) to characterize safety, tolerability and brain microglia response, as measured by TSPO binding, following multiple doses of BLZ945 using positron emission tomography (PET) with the radioligand [11C]-PBR28 Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BLZ945
INN or Proposed INN: Not yet defined
Other descriptive name: BLZ945
Product Code: BLZ945
INN or Proposed INN: Not yet defined
Other descriptive name: BLZ945
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2United States;Finland;Sweden
209EUCTR2019-000374-39-PL
(EUCTR)
05/09/201922/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Sweden
210EUCTR2018-004180-31-GB
(EUCTR)
05/09/201901/11/2019An open label extension for patients completing study 3119002 to studythe effects of oral Levosimendan on breathing function in patients with thedisease Amyotrophic Lateral Sclerosis (ALS)Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
211NCT03474263
(ClinicalTrials.gov)
September 1, 20199/3/2018IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients WithAmyotrophic Lateral SclerosisBiological: Biologic: IC14 (monoclonal antibody against human CD14)Implicit BioscienceNULLWithdrawn18 Years80 YearsAll0Phase 2Australia;United States
212NCT04081714
(ClinicalTrials.gov)
August 31, 20195/9/2019Intermediate Expanded Access Protocol for ALSAn Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8Amyotrophic Lateral SclerosisDrug: CNM-Au8Clene NanomedicineMassachusetts General HospitalAvailable18 YearsN/AAllUnited States
213EUCTR2019-000374-39-NL
(EUCTR)
27/08/201929/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
214EUCTR2018-004180-31-AT
(EUCTR)
22/08/201903/05/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
215EUCTR2018-004180-31-FI
(EUCTR)
15/08/201925/04/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
216NCT03508453
(ClinicalTrials.gov)
August 15, 201916/4/2018IC14 for Treatment of Amyotrophic Lateral SclerosisA Phase 2, Randomised, Double-Blind, Placebo-Controlled Study of IC14 for Treatment of Patients With Rapidly Progressive Motor Neuron DiseaseAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseBiological: IC14;Other: PlaceboImplicit BioscienceNULLWithdrawn18 Years75 YearsAll0Phase 2Australia
217NCT04055623
(ClinicalTrials.gov)
August 7, 201912/8/2019T-regulatory Cells in ALSPhase 2a Study of the Expansion and Infusion of Autologous T-Regulatory Cells in Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis)Biological: Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections;Other: Monthly placebo infusions + 3 times per week placebo injectionsThe Methodist Hospital Research InstituteMassachusetts General Hospital;The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston;North East Amyotrophic Lateral Sclerosis ConsortiumActive, not recruiting18 YearsN/AAll12Phase 2United States
218EUCTR2019-000374-39-ES
(EUCTR)
07/08/201911/06/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
219NCT03883581
(ClinicalTrials.gov)
July 25, 201912/3/2019Impact of Nuedexta on Bulbar Physiology and Function in ALSImpact of Nuedexta on Bulbar Physiology and Function in ALSAmyotrophic Lateral SclerosisDrug: dextromethorphan HBr and quinidine sulfateUniversity of FloridaHoly Cross Hospital, Florida;ALS AssociationCompleted18 Years90 YearsAll28Phase 1/Phase 2United States
220EUCTR2018-004180-31-IT
(EUCTR)
24/07/201918/01/2021An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: [ODM-109]
INN or Proposed INN: LEVOSIMENDAN
ORION CORPORATION ORION PHARMANULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
221ChiCTR1900024520
2019-07-222019-07-13Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosisSplit-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis Amyotrophic lateral sclerosisGold Standard:Clinical outcome meet the Awaji-Shima Criteria 2008;Index test:Split-hand index calculated by F-wave test;Peking Union Medical College HospitaNULLRecruiting1880BothTarget condition:300;Difficult condition:50N/AChina
222EUCTR2019-000374-39-IT
(EUCTR)
15/07/201927/01/2021Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial - na Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: [BRX-345]
INN or Proposed INN: ARIMOCLOMOL
ORPHAZYME APSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
223EUCTR2019-000374-39-GB
(EUCTR)
15/07/201909/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
224NCT03948178
(ClinicalTrials.gov)
June 26, 20197/5/2019Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label ExtensionEffects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002Amyotrophic Lateral SclerosisDrug: LevosimendanOrion Corporation, Orion PharmaNULLCompleted18 Years120 YearsAll227Phase 3Spain
225NCT04140136
(ClinicalTrials.gov)
June 17, 201921/10/2019The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory StudyAmyotrophic Lateral SclerosisDietary Supplement: Tocotrienols;Dietary Supplement: PlaceboUniversity of MalayaNULLRecruitingN/AN/AAll20Phase 2Malaysia
226EUCTR2018-004180-31-DE
(EUCTR)
17/06/201912/04/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
227EUCTR2018-002722-22-BE
(EUCTR)
06/06/201919/02/2019Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TUDCABIL
INN or Proposed INN: tauroursodeoxycholic acid
Other descriptive name: TAUROURSODEOXYCHOLIC ACID
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3Belgium;Netherlands;Germany;Italy;United Kingdom
228EUCTR2018-002722-22-DE
(EUCTR)
03/06/201905/02/2019Safety and efficacy of a treatment with tauroursodeoxycholic acid (TUDCA) on top of riluzole in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TUDCABIL
INN or Proposed INN: tauroursodeoxycholic acid
Other descriptive name: TAUROURSODEOXYCHOLIC ACID
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3Belgium;Netherlands;Germany;Italy;United Kingdom
229NCT03945279
(ClinicalTrials.gov)
May 30, 20198/5/2019A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral SclerosisA Phase 1, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adult Participants With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: BIIB100;Drug: PlaceboBiogenNULLCompleted18 YearsN/AAll49Phase 1United States
230EUCTR2018-002722-22-GB
(EUCTR)
20/05/201928/02/2019Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS amyotrophic lateral sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Taurolite
Product Name: Taurolite
INN or Proposed INN: Tauroursodeoxycholic acid
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Netherlands;United Kingdom
231EUCTR2018-004180-31-ES
(EUCTR)
16/05/201912/04/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
232EUCTR2018-004180-31-BE
(EUCTR)
29/04/201915/03/2019An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
233NCT04176224
(ClinicalTrials.gov)
April 17, 201922/11/2019Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral SclerosisClinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)Japanese Patients With ALSDrug: MT-1186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years75 YearsAll9Phase 1Japan
234NCT03693781
(ClinicalTrials.gov)
April 10, 201930/9/2018Colchicine for Amyotrophic Lateral SclerosisColchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical TrialAmyotrophic Lateral SclerosisDrug: Colchicine 1 MG Oral Tablet;Drug: Placebo Oral TabletAzienda Ospedaliero-Universitaria di ModenaUniversity of Modena and Reggio Emilia;University of Turin, Italy;Istituto Auxologico Italiano;IRCCS National Neurological Institute C. Mondino Foundation;University of Bari;IRCCS San Raffaele;University of Padova;University of Milan;Istituto Di Ricerche Farmacologiche Mario Negri;University of Campania Luigi Vanvitelli;Catholic University of the Sacred HeartCompleted18 Years80 YearsAll54Phase 2Italy
235NCT02437110
(ClinicalTrials.gov)
April 1, 20195/5/2015HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Darunavir;Drug: Ritonavir;Drug: Dolutegravir;Drug: Tenofovir alafenamide (TAF)National Institute of Neurological Disorders and Stroke (NINDS)NULLActive, not recruiting18 YearsN/AAll122Phase 1United States
236JPRN-jRCT2051190001
29/03/201901/04/2019Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS)Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) amyotrophic lateral sclerosis
ALS
The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period.
3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design.
Inoue HaruhisaNULLRecruiting20age79ageBoth24Phase 1Japan
237JPRN-UMIN000036295
2019/03/2926/03/2019Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS)Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral SclerosisThe study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period.
3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design.
Center for iPS Cell Research and Application, Kyoto UniversityProvider of the investigational product: Pfizer Japan Inc.Complete: follow-up complete20years-old80years-oldMale and Female24Phase 1Japan
238NCT03705390
(ClinicalTrials.gov)
March 29, 201911/9/2018A Safety and Tolerability Study of ILB in Patients With Amyothrophic Lateral Sclerosis (ALS)A Phase II Pilot Single-arm Safety and Tolerability Study of ILB in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: ILBUniversity of BirminghamTikoMed AB;University Hospital Birmingham;NeuregenixCompleted18 YearsN/AAll11Phase 2United Kingdom
239JPRN-JMA-IIA00419
29/03/201929/03/2019Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS)Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral SclerosisIntervention type:DRUG. Intervention1:Medicine, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. .Center for iPS Cell Research and Application (CiRA), Kyoto UniversityNULLRecruiting>=20 YEARS<80 YEARSBOTH24Phase 1Japan
240EUCTR2017-002754-36-FR
(EUCTR)
27/03/201927/11/2018Effects of oral levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
241NCT04744532
(ClinicalTrials.gov)
March 19, 20199/1/2021iPSC-based Drug Repurposing for ALS Medicine (iDReAM) StudyPhase 1/2 Study of Bosutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Bosutinib (Phase 1 part);Drug: Bosutinib (Phase 2 part)Kyoto UniversityTokushima University;Kitasato University;Tottori University;Nara Medical University;Toho University;Hiroshima University;PfizerRecruiting20 Years75 YearsAll49Phase 1/Phase 2Japan
242NCT03800524
(ClinicalTrials.gov)
February 22, 20194/1/2019Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALSSafety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Tauroursodeoxycholic Acid;Drug: PlaceboHumanitas Mirasole SpAUniversity of Ulm;University of Sheffield;University Hospital, Tours;KU Leuven;UMC Utrecht;University of Dublin, Trinity College;Bruschettini S.r.l.;Istituto Superiore di Sanità;Motor Neurone Disease Association;European CommissionActive, not recruiting18 Years80 YearsAll337Phase 3Belgium;France;Germany;Ireland;Italy;Netherlands;United Kingdom
243NCT03792490
(ClinicalTrials.gov)
February 20, 201928/12/2018Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALSInhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALSAmyotrophic Lateral SclerosisDrug: Fasudil;Drug: PlaceboUniversity Medical Center GoettingenNULLActive, not recruiting18 YearsN/AAll120Phase 2France;Germany;Switzerland
244NCT03690791
(ClinicalTrials.gov)
January 9, 201913/9/2018Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone DiseaseA Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease PatientsAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: MediCabilis CBD Oil;Drug: Placebo OilGold Coast Hospital and Health ServiceBOD AustraliaRecruiting25 Years80 YearsAll30Phase 3Australia
245NCT03293069
(ClinicalTrials.gov)
January 1, 201921/9/2017Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral SclerosisConservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis: Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of DeferiproneAmyotrophic Lateral SclerosisDrug: Deferiprone;Drug: Placebo Oral TabletUniversity Hospital, LilleMinistry of Health, FranceActive, not recruiting18 Years75 YearsAll372Phase 2/Phase 3France
246EUCTR2018-002722-22-IT
(EUCTR)
18/12/201818/01/2021Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TUDCABIL
Product Name: TUDCABIL
Product Code: [TUDCA]
INN or Proposed INN: ACIDO TAUROURSODESOSSICOLICO
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3France;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy
247NCT03757351
(ClinicalTrials.gov)
December 14, 201827/11/2018Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral SclerosisA Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL747 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: DNL747;Drug: PlaceboSanofiDenali Therapeutics Inc.Terminated21 Years80 YearsAll15Phase 1United States;Netherlands
248NCT03755167
(ClinicalTrials.gov)
December 9, 201821/11/2018A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IVAn Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) PatientsAmyotrophic Lateral Sclerosis (ALS)Drug: IPL344Immunity Pharma Ltd.NULLRecruiting18 Years75 YearsAll15Phase 2Israel
249JPRN-JMA-IIA00397
05/12/201826/11/2018Phase 1/2a Study of Ropinirole Hydrochloride Extended-Release Tablets in Patients with Amyotrophic Lateral Sclerosis (ALS)Phase 1/2a, Double-blind, Placebo-controlled Study with an Open-label Extension of Ropinirole Hydrochloride Extended-Release Tablets-Explorative Assessment of the Safety, Tolerability, and Efficacy after Oral Treatment in Patients with Amyotrophic Lateral Sclerosis (ALS)- amyotrophic lateral sclerosis (ALS)Intervention type:DRUG. Intervention1:Requip CR tablets, Dose form:SUSTAINED-RELEASE TABLET, Route of administration:ORAL, intended dose regimen:Once daily ropinirole hydrochloride extended-release tablet with dose-escalation tolerable from 2mg to 16mg for 24 weeks (Interventions). Control intervention1:Placebo, Dose form:SUSTAINED-RELEASE TABLET, Route of administration:ORAL, Intended dose regimen:Once daily placebo tablet with dose-escalation tolerable from 2mg to 16mg for 24 weeks (Interventions).noneNULLCompleted>=20 YEARS<=80 YEARSBOTH20Phase 1-2Japan
250EUCTR2018-000137-13-BE
(EUCTR)
04/12/201813/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
251NCT03793868
(ClinicalTrials.gov)
December 4, 201828/12/2018Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral SclerosisPerampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Perampanel;Other: PlaceboMayo ClinicNULLCompleted18 Years70 YearsAll22Early Phase 1United States
252NCT03944447
(ClinicalTrials.gov)
December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as MedicineOutcomes Mandate National Integration With Cannabis as MedicineChronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;CoronavirusDrug: Cannabis, Medical;Device: RYAH-Medtech InhalerOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
253EUCTR2018-000137-13-NL
(EUCTR)
21/11/201818/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3France;United States;Canada;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
254EUCTR2018-000137-13-GB
(EUCTR)
19/11/201807/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
231 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
255NCT02118727
(ClinicalTrials.gov)
November 7, 201815/4/2014Therapy in Amyotrophic Lateral Sclerosis (TAME)Multi-centered Double Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Memantine at 20 mg BID in Patients With ALSAmyotrophic Lateral Sclerosis;Frontal Temporal DementiaDrug: Memantine;Drug: Placebo (for Memantine)University of Kansas Medical CenterUniversity of Missouri-ColumbiaCompleted18 Years85 YearsAll90Phase 2United States
256NCT03580616
(ClinicalTrials.gov)
October 24, 201826/6/2018Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa StudyAmyotrophic Lateral Sclerosis (ALS)Drug: L-SerineElijah W. StommelBrain Chemistry Labs, Institute for EthnomedicineSuspended18 YearsN/AAll50Phase 2United States
257EUCTR2018-000137-13-SE
(EUCTR)
22/10/201807/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
258EUCTR2018-000137-13-ES
(EUCTR)
19/10/201809/10/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3France;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
259EUCTR2018-000137-13-PL
(EUCTR)
18/10/201802/10/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
260EUCTR2018-000137-13-IT
(EUCTR)
08/10/201822/01/2021A study to compare the use of Arimoclomol with placebo in patients withAmyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis - na Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: [BRX-345]
INN or Proposed INN: ARIMOCLOMOL
ORPHAZYME APSNULLNot RecruitingFemale: yes
Male: yes
231Phase 3France;United States;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
261EUCTR2018-000137-13-FR
(EUCTR)
05/10/201806/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
262EUCTR2018-000586-37-IE
(EUCTR)
13/09/201808/05/2018A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: Reldesemtiv
Other descriptive name: Reldesemtiv
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Ireland;Australia;Netherlands
263EUCTR2017-004459-21-IT
(EUCTR)
11/09/201807/11/2018Study evaluating the treatment with colchicine for the amyotrophic lateral sclerosisColchicine for Amyotrophic Lateral Sclerosis: a phase II, randomized, double blind, placebo controlled, multicenter clinical trial - Co-ALS Definite or probable amyotrophic lateral sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10052889;Term: ALS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: COLCHICINA LIRCA - 1 MG COMPRESSE 60 COMPRESSE
Product Name: Colchicina
Product Code: Colchicina
INN or Proposed INN: COLCHICINA
Other descriptive name: COLCHICINA
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2Italy
264NCT03626012
(ClinicalTrials.gov)
September 10, 20187/8/2018A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral SclerosisA Phase 1 Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 Administered Intrathecally to Adults With C9ORF72-Associated Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: BIIB078;Drug: PlaceboBiogenNULLCompleted18 YearsN/AAll106Phase 1United States;Canada;Ireland;Netherlands;Switzerland;United Kingdom
265EUCTR2016-003225-41-DE
(EUCTR)
06/09/201815/09/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand
266EUCTR2017-002754-36-NL
(EUCTR)
30/08/201822/05/2018Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
267EUCTR2018-000586-37-NL
(EUCTR)
15/08/201804/06/2018A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: Reldesemtiv
Other descriptive name: Reldesemtiv
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Ireland;Australia;Netherlands
268NCT03613571
(ClinicalTrials.gov)
August 15, 201815/6/2018A Study to Evaluate the Safety, Tolerability and Efficacy of ILB in Patients With Amyotrophic Lateral SclerosisA Single-centre, Open Single-arm Study Where the Safety, Tolerability and Efficacy of Subcutaneously Administered ILB Will be Evaluated in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: ILBTikoMed ABNULLTerminated18 Years80 YearsAll13Phase 2Sweden
269EUCTR2018-000668-28-GB
(EUCTR)
09/08/201825/06/2018A study to assess safety and acceptability of a treatment in patients with ALSA Phase II pilot safety and tolerability study of ILB in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) - The ALS Study Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ILB: 100mg/ml solution for injection and infusion
INN or Proposed INN: Dextran Sodium Sulfur Salt 5, Mw 5 kDa. a type of Low Molecular Weight Dextran Sulfate (LMW-DS)
Other descriptive name: ILB
University of BirminghamNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
270NCT03652805
(ClinicalTrials.gov)
August 1, 201813/8/2018A Study of IPL344 in the Treatment of ALS PatientsPhase 1/2a, Multi-center, Open-Label, Dose-escalating Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenously Administered IPL344 for The Treatment of Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: IPL344Immunity Pharma Ltd.NULLRecruiting18 Years80 YearsAll15Phase 1/Phase 2Israel
271NCT03491462
(ClinicalTrials.gov)
July 31, 201827/3/2018Arimoclomol in Amyotropic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Arimoclomol;Drug: Placebo oral capsuleOrphazymeNULLCompleted18 YearsN/AAll245Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom;Denmark
272EUCTR2018-000586-37-ES
(EUCTR)
19/07/201823/05/2018A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: Reldesemtiv
Other descriptive name: Reldesemtiv
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Ireland;Australia;Netherlands
273EUCTR2017-002754-36-IT
(EUCTR)
05/07/201801/10/2021Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: [ODM-109]
INN or Proposed INN: LEVOSIMENDAN
ORION CORPORATION ORION PHARMANULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
274JPRN-jRCT2071210022
03/07/201812/05/2021Clinical Pharmacology Study of EPI-589Clinical Pharmacology Study of EPI-589 (DA301006) Amyotrophic lateral sclerosisPart A : Single oral administration (EPI-589 250, 500, 1000 mg/day or placebo)
Part B : Single oral administration (EPI-589 500 mg/day or placebo)
Part C : Multiple oral administration (EPI-589 1000, 1500 mg/day or placebo)
Part D : Single oral administration (EPI-589 500 mg/day)
Hamatani TatsutoNULLComplete>= 20age old<= 55age oldMale68Phase 1Japan
275NCT03505021
(ClinicalTrials.gov)
June 21, 201816/4/2018Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALSEffects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALSAmyotrophic Lateral SclerosisDrug: Levosimendan;Drug: Placebo for levosimendanOrion Corporation, Orion PharmaNULLCompleted18 Years120 YearsAll496Phase 3United States;Australia;Austria;Belgium;Canada;Finland;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
276NCT03506425
(ClinicalTrials.gov)
June 21, 201813/4/2018A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS)A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS)ALSDrug: TriheptanoinRichard Bedlack, M.D., Ph.D.Ultragenyx Pharmaceutical IncCompleted18 YearsN/AAll15Phase 1/Phase 2United States
277NCT03472950
(ClinicalTrials.gov)
June 11, 20181/3/2018Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral SclerosisSafety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral SclerosisALSDrug: Ranolazine 500 MG;Drug: Ranolazine 1000 MGUniversity of Kansas Medical CenterGilead SciencesRecruiting18 YearsN/AAll20Phase 2United States
278NCT03537807
(ClinicalTrials.gov)
June 20189/5/2018Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;ALS;Lou Gehrig Disease;Lou Gehrig's Disease;Lou-Gehrigs Disease;Motor Neuron Disease, Amyotrophic Lateral SclerosisDrug: RiluzoleBiohaven Pharmaceuticals, Inc.NULLNo longer available18 YearsN/AAllNULL
279EUCTR2017-003763-35-FR
(EUCTR)
17/05/201805/03/2018conservative iron chelation by deferiprone for amyotrophic lateral sclerosisConservative Iron Chelation by Deferiprone as a disease-modifying Strategy for Amyotrophic Lateral Sclerosis using a Multicentre Parallel group, placebo controlled, Randomized clinical trial - FAIR ALS II De novo Amyotrophic Lateral Sclerosis patients;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Deferiprone DR
INN or Proposed INN: DEFERIPRONE
centre hospitalier universitaire de LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3France
280EUCTR2017-002754-36-BE
(EUCTR)
15/05/201828/02/2018Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
281EUCTR2017-005065-47-SE
(EUCTR)
15/05/201819/03/2018A single-center, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis.A single-centre, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: ILB
Product Code: ILB
INN or Proposed INN: ILB
Other descriptive name: DEXTRAN SULFATE SODIUM
TikoMed ABNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSweden
282EUCTR2018-000142-18-FI
(EUCTR)
09/05/201808/05/2018Feasibility and effects of subcutaneously given combination of dexmedetomidine and ketamine in ALS patients receiving palliative careFeasibility and pharmacodynamics of subcutaneously given combination of dexmedetomidine and ketamine infusion in ALS patients receiving palliative care Amyotrophic lateral sclerosis (ALS)
MedDRA version: 20.1;Level: LLT;Classification code 10036704;Term: Primary lateral sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE
Trade Name: Ketanest-S
INN or Proposed INN: ESKETAMINE
Turku University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Finland
283EUCTR2017-002754-36-IE
(EUCTR)
08/05/201825/01/2018Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
284EUCTR2017-002754-36-GB
(EUCTR)
04/05/201830/01/2018Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3Germany;Netherlands;Sweden;United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia
285EUCTR2017-002754-36-ES
(EUCTR)
29/04/201814/03/2018Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
286EUCTR2017-002754-36-FI
(EUCTR)
19/04/201828/02/2018Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
287EUCTR2017-002754-36-AT
(EUCTR)
17/04/201808/03/2018Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS Amyotrophic lateral sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
INN or Proposed INN: LEVOSIMENDAN
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
288NCT03482050
(ClinicalTrials.gov)
April 12, 201814/3/2018A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase I/IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Theraputic Effects of Transplantation of Astrocytes Derived From Human Embryonic Stem Cells (hESC), in Patients With Amyotrophic Lateral Sclerosis (ALS)ALS (Amyotrophic Lateral Sclerosis)Biological: AstroRxKadimastemNULLCompleted18 Years70 YearsAll16Phase 1/Phase 2Israel
289NCT03334786
(ClinicalTrials.gov)
April 5, 201826/10/2017Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALSAn Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and One Appendicular Muscle in Adult Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;FasciculationDrug: FLX-787-ODTFlex Pharma, Inc.NULLTerminated18 YearsN/AAll3Phase 1/Phase 2United States
290NCT03679975
(ClinicalTrials.gov)
April 4, 201819/9/2018Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Riluzole Oral Soluble film (ROSF) 50 mgAquestive TherapeuticsinVentiv Health Clinical;CovanceTerminated18 Years80 YearsAll9Phase 2United States
291NCT03488524
(ClinicalTrials.gov)
March 29, 201823/3/2018Open Label Extension Study of AMX0035 in Patients With ALSOpen Label Extension Study of AMX0035 in Patients With ALSAmyotrophic Lateral Sclerosis;ALSDrug: AMX0035Amylyx Pharmaceuticals Inc.Massachusetts General Hospital Neurology Clinical Research InstituteCompletedN/AN/AAll95Phase 2United States
292NCT03457753
(ClinicalTrials.gov)
March 1, 201826/2/2018Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral SclerosisA Multi-Center, Open Label Study to Assess the Safety and Tolerability of Riluzole Oral Soluble Film in Subjects With Amyotrophic Lateral Sclerosis Over 12 Weeks of Twice Daily Treatment.ALSDrug: Riluzole Oral Soluble FilmAquestive TherapeuticsInventiv Health;CovanceWithdrawn18 Years80 YearsAll0Phase 2United States
293NCT03520517
(ClinicalTrials.gov)
February 2, 201817/4/2018Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALSOpen-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;ALS;Lou Gehrig Disease;Lou Gehrig's Disease;Lou-Gehrigs Disease;Motor Neuron Disease, Amyotrophic Lateral SclerosisDrug: BHV-0223Biohaven Pharmaceuticals, Inc.Cognitive Research CorporationCompleted18 YearsN/AAll22Phase 1United States
294NCT03427086
(ClinicalTrials.gov)
January 29, 201829/1/2018Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral SclerosisSafety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Biotin;Drug: Placebo Oral TabletAmerican University of Beirut Medical CenterNULLCompleted18 Years80 YearsAll12Phase 2Lebanon
295NCT03136809
(ClinicalTrials.gov)
January 18, 201828/4/2017ALS Treatment Extension StudyA Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Completed Study CMD-2016-001Amyotrophic Lateral SclerosisDrug: Cu(II)ATSMCollaborative Medicinal Development Pty LimitedNULLActive, not recruiting18 Years75 YearsAll28Phase 1/Phase 2Australia
296NCT03548311
(ClinicalTrials.gov)
November 1, 201714/5/2018Clinical Trial of Ultra-high Dose Methylcobalamin for ALSJapanese Early-stage Clinical Trial of Ultra-high Dose Methylcobalamin for Amyotrophic Lateral Sclerosis: a Pivotal Phase 3 Randomized Controlled StudyAmyotrophic Lateral SclerosisDrug: methylcobalamin;Drug: saline solutionUniversity of TokushimaEisai Co., Ltd.Unknown status20 YearsN/AAll128Phase 3Japan
297NCT03338114
(ClinicalTrials.gov)
November 20176/11/2017Study to Evaluate the Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With ALSAn Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;FasciculationDrug: FLX-787-ODT (orally disintigrating tablet)Flex Pharma, Inc.NULLWithdrawn18 YearsN/AAll0Phase 1/Phase 2United States
298NCT03272503
(ClinicalTrials.gov)
October 27, 201731/8/2017A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II Randomized, Placebo-Controlled, Double Blinded, Multi-Centre Clinical Trial of Pimozide in Patients With Amyotrophic Lateral SclerosisALS;Amyotrophic Lateral SclerosisDrug: Pimozide 2mg/day (current) or 4 mg/day (study initiation);Drug: Placebo Oral TabletUniversity of CalgaryALS Canada;Brain CanadaRecruiting18 YearsN/AAll100Phase 2Canada
299NCT03268603
(ClinicalTrials.gov)
October 10, 201730/8/2017Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)A Phase II Study of Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral SclerosisALS;Amyotrophic Lateral SclerosisDrug: Autologous Adipose-derived Mesenchymal Stromal CellsMayo ClinicState of Minnesota Regenerative Medicine MinnesotaActive, not recruiting18 YearsN/AAll75Phase 2United States
300NCT03168711
(ClinicalTrials.gov)
October 1, 201724/5/2017Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Inosine;Drug: PlaceboMassachusetts General HospitalThe Salah Foundation;MGH cure ALS FundCompleted18 Years85 YearsAll23Phase 2United States
301NCT03487263
(ClinicalTrials.gov)
October 1, 20179/3/2018Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone DiseaseA Phase 1b, Open-Label, Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone DiseaseMotor Neuron Disease;Amyotrophic Lateral SclerosisBiological: IC14Implicit BioscienceRoyal Brisbane and Women's HospitalCompleted18 Years75 YearsAll10Phase 1Australia
302EUCTR2016-003225-41-GB
(EUCTR)
20/09/201702/06/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - Biogen 233AS102 Study of BIIB067 in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: -
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 1;Phase 3United States;Japan;United Kingdom;Spain;Canada;Sweden;Belgium;Denmark;Poland;Italy;Australia;France;Germany
303EUCTR2016-002629-13-BE
(EUCTR)
04/09/201721/04/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom
304EUCTR2016-002629-13-PT
(EUCTR)
28/08/201704/05/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
305NCT03280056
(ClinicalTrials.gov)
August 28, 201729/8/2017Safety and Efficacy of Repeated Administrations of NurOwn® in ALS PatientsA Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALSAmyotrophic Lateral Sclerosis (ALS)Biological: NurOwn® (MSC-NTF cells);Other: Placebo;Other: Bone Marrow aspirationBrainstorm-Cell TherapeuticsCalifornia Institute for Regenerative Medicine (CIRM)Completed18 Years60 YearsAll263Phase 3United States
306NCT03707795
(ClinicalTrials.gov)
August 21, 201714/9/2017Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE StudyTreatment of FUS-Related ALS With Betamethasone - The TRANSLATE StudyFamilial Amyotrophic Lateral SclerosisDrug: Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four daysEdward KasaraskisNULLCompleted20 Years80 YearsAll6Early Phase 1United States
307NCT03237741
(ClinicalTrials.gov)
August 7, 201731/7/2017Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female ParticipantsA Phase I Open-Label Study to Determine the Relative Bioavailability of GDC-0134 and to Investigate the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Subjects of Non-childbearing PotentialAmyotrophic Lateral SclerosisDrug: Reference capsule GDC-0134;Drug: Prototype capsule GDC-0134;Drug: rabeprazoleGenentech, Inc.Quotient ClinicalCompleted30 Years65 YearsFemale24Phase 1United Kingdom
308NCT03160898
(ClinicalTrials.gov)
July 24, 201712/5/2017A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Reldesemtiv;Drug: PlaceboCytokineticsAstellas Pharma IncCompleted18 Years80 YearsAll458Phase 2United States;Australia;Canada;Ireland;Netherlands;Spain
309JPRN-UMIN000029308
2017/07/1830/09/2018Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination.Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination. - Effect of febuxostat and inosine on amyotrophic lateral sclerosis Amyotrophic lateral sclerosisFebuxostat 20 mg, Inosine 500 mg, twice a day for 14 daysTeikyo UniversityNULLComplete: follow-up complete20years-old80years-oldMale and Female3Not applicableJapan
310EUCTR2016-002399-28-IT
(EUCTR)
14/07/201723/01/2018Rapamycin (Sirolimus) treatment for amyotrophic lateral sclerosisRapamycin (Sirolimus) treatment for amyotrophic lateral sclerosis - RAP.ALS definite or probable ALS
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: RAPAMUNE - 1 MG 100 COMPRESSE RIVESTITE IN BLISTER USO ORALE
Product Name: Rapamune
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2Italy
311NCT03186040
(ClinicalTrials.gov)
July 13, 20175/6/2017Open-label Clinical Trial of Lacosamide in ALSOpen-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: LacosamideChiba UniversityNULLCompleted20 YearsN/AAll7Phase 1/Phase 2Japan
312JPRN-jRCTs031180173
07/07/201701/03/2019Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis amyotrophic lateral sclerosis
amyotrophic lateral sclerosis;G122
gradual increase of lacosamide from 100mg to 400mg for 4 weeksKuwabara SatoshiNULLComplete>= 20age oldNot applicableBoth30Phase 1-2Japan
313NCT03127514
(ClinicalTrials.gov)
June 22, 201712/4/2017AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for the Treatment of ALSAmyotrophic Lateral Sclerosis;Motor Neuron Disease;Neuromuscular Diseases;Neurodegenerative Diseases;Spinal Cord Diseases;TDP-43 Proteinopathies;Nervous System Diseases;Central Nervous System DiseasesDrug: AMX0035;Other: PlaceboAmylyx Pharmaceuticals Inc.ALS Finding a Cure Foundation;ALS Association;Northeast ALS Consortium;Massachusetts General Hospital Neurology Clinical Research Institute;Leandro P. Rizzuto FoundationCompleted18 Years80 YearsAll137Phase 2/Phase 3United States
314NCT03068754
(ClinicalTrials.gov)
June 22, 201723/2/2017Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Acthar;Drug: PlaceboMallinckrodtNULLTerminated18 Years75 YearsAll143Phase 2/Phase 3United States;Argentina;Canada;Chile;Colombia;Mexico;Peru
315NCT03039673
(ClinicalTrials.gov)
June 19, 201731/1/2017MIROCALS: Modifying Immune Response and OutComes in ALSEfficacy and Safety of Low-dose IL-2 (Ld-IL-2) as a Treg Enhancer for Controlling Neuro-inflammation in Newly Diagnosed Amyotrophic Lateral Sclerosis (ALS) Patients: A Randomized, Double-blind, Placebo- Controlled, Phase-II Proof of Concept/ Proof of Mechanism Clinical TrialAmyotrophic Lateral SclerosisDrug: Riluzole;Drug: IL-2;Drug: 5% glucose water solutionCentre Hospitalier Universitaire de NimesNULLCompleted18 Years75 YearsAll304Phase 2France;United Kingdom
316EUCTR2016-002629-13-NL
(EUCTR)
07/06/201714/03/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom
317EUCTR2016-002629-13-GB
(EUCTR)
05/06/201709/02/2018An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
318JPRN-UMIN000027476
2017/06/0101/06/2017Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis - Open-label clinical trial of lacosamide in ALS amyotrophic lateral sclerosisgradual increase of lacosamide from 100mg to 400mg for 4 weeksDepartment of Neurology Chiba University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
319NCT03324399
(ClinicalTrials.gov)
June 1, 20175/9/2017A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With ALSA Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;ALSDietary Supplement: probioticAvera McKennan Hospital & University Health CenterNULLCompleted18 YearsN/AAll5N/AUnited States
320EUCTR2016-002629-13-FR
(EUCTR)
22/05/201716/05/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;France;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
321JPRN-UMIN000025614
2017/04/2401/02/2017Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 TrialPerampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial - Perampanel for sporadic amyotrophic lateral sclerosis (ALS) Sporadic amyotrophic lateral sclerosisOnce daily perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks (Interventions)
Once daily perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks (Interventions).
Once daily placebo for 48 weeks (Control)
Department of Neurology, Tokyo Medical UniversityNULLComplete: follow-up complete40years-old78years-oldMale and Female60Phase 2Japan
322NCT03103815
(ClinicalTrials.gov)
April 24, 20171/4/2017Trial of Amivita in Amyotrophic Lateral SclerosisTrial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical TrialAmyotrophic Lateral SclerosisDrug: AmivitaWujin People's HospitalNanjing 1718 Biotech Co. LtdRecruiting18 Years70 YearsAll30N/AChina
323NCT03019419
(ClinicalTrials.gov)
April 24, 201710/1/2017Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 TrialsALSDrug: Perampanel;Drug: placeboTokyo Medical UniversityNULLCompleted40 Years78 YearsAll66Phase 2Japan
324EUCTR2016-002629-13-ES
(EUCTR)
12/04/201710/03/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
325EUCTR2016-003225-41-BE
(EUCTR)
10/04/201710/04/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
INN or Proposed INN: Tofersen
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;Korea, Republic of
326NCT03049046
(ClinicalTrials.gov)
April 7, 20173/2/2017CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALSProtocol CC100B. CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALSAmyotrophic Lateral SclerosisDrug: CC100;Drug: PlacebosChemigen, LLCNULLRecruiting18 Years64 YearsAll21Phase 1United States
327NCT02943850
(ClinicalTrials.gov)
April 1, 201720/10/2016CNS10-NPC-GDNF for the Treatment of ALSHuman Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Stem cell (HPC) implantation;Device: Stereotactic surgical deviceCedars-Sinai Medical CenterCalifornia Institute for Regenerative Medicine (CIRM)Completed18 YearsN/AAll18Phase 1United States
328EUCTR2016-002629-13-IT
(EUCTR)
28/03/201720/01/2021An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
CYTOKINETICS, INC.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy
329NCT03272802
(ClinicalTrials.gov)
March 16, 20172/9/2017Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian PopulationNeuromuscular DiseasesDrug: Edaravone;Drug: RiluzoleIsfahan University of Medical SciencesNULLActive, not recruiting18 Years75 YearsAll20Phase 2/Phase 3Iran, Islamic Republic of
330NCT03070119
(ClinicalTrials.gov)
March 8, 201728/2/2017Long-Term Evaluation of BIIB067An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 MutationALS Caused by Superoxide Dismutase 1 (SOD1) MutationDrug: BIIB067BiogenIonis Pharmaceuticals, Inc.Active, not recruiting18 YearsN/AAll138Phase 3United States;Belgium;Canada;France;Germany;Italy;Japan;New Zealand;United Kingdom
331JPRN-UMIN000026221
2017/03/0201/03/2017Safety of perampanel in patients with motor neuron diseaseSafety of perampanel in patients with motor neuron disease - Safety of perampanel in patients with motor neuron disease amyotrophic lateral sclerosisOnce daily perampanel with dose escalation from 2mg to 8mg.Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female15Phase 1Japan
332EUCTR2016-002629-13-IE
(EUCTR)
28/02/201725/11/2016An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
333NCT03214146
(ClinicalTrials.gov)
February 1, 20179/7/2017Safety/Efficacy Study of 2nd Cycle Treatment After 6 Months of 1st Cycle HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell Treatment in ALSAn Open-label, Phase 1 Trial for Safety and Efficacy Study of 2nd Cycle Treatment After 6 Months of 1st Cycle HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell(HYNR-CS-Allo Inj) Treatment in Amyotrophic Lateral Sclerosis(ALS)Amyotrophic Lateral SclerosisBiological: HYNRCS-Allo injHanyang University Seoul HospitalCorestem, Inc.Active, not recruiting25 Years80 YearsAll6Phase 1Korea, Republic of
334EUCTR2016-002382-62-IT
(EUCTR)
13/01/201722/06/2021The effects of RNS60 on ALS biomarkersThe effects of RNS60 on ALS biomarkers - RNS60-ALS Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10052889;Term: ALS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: RNS60
Product Code: RNS60
Product Name: RNS60
Product Code: RNS60
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 2United States;Italy
335NCT03020797
(ClinicalTrials.gov)
January 12, 201715/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Perampanel;Drug: Placebo Oral TabletStony Brook UniversityEisai Inc.Recruiting18 Years80 YearsAll60N/AUnited States
336NCT03073239
(ClinicalTrials.gov)
December 201626/3/2016Amyotrophic Lateral Sclerosis: a New ParadigmAmyotrophic Lateral Sclerosis: a New ParadigmAmyotrophic Lateral SclerosisGenetic: ALS patients genetic characterization;Other: ALS patients epidemiological caracterizationConde, Bebiana, M.D.NULLCompleted18 YearsN/AAll30Portugal
337EUCTR2014-005413-23-IE
(EUCTR)
30/11/201610/09/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
338NCT03456882
(ClinicalTrials.gov)
November 18, 20162/2/2018The Effect of RNS60 on ALS BiomarkersThe Effect of RNS60 on ALS BiomarkersAmyotrophic Lateral SclerosisDrug: RNS60Mario Negri Institute for Pharmacological ResearchALS Association;Get out ONLUSCompleted18 Years80 YearsAll142Phase 2United States;Italy
339NCT02870634
(ClinicalTrials.gov)
November 16, 201610/8/2016Phase 1 Dose Escalation and PK Study of Cu(II)ATSM in ALS/MNDA Phase 1 Single and Multiple Dose Escalation and Pharmacokinetic Study of Cu(II)ATSM Administered Orally to Patients With Amyotrophic Lateral Sclerosis/Motor Neuron DiseaseAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: Cu(II)ATSMCollaborative Medicinal Development Pty LimitedNULLCompleted18 Years75 YearsAll50Phase 1Australia
340JPRN-UMIN000024854
2016/11/1616/11/2016Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosisClinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis - Clinical study for the anti-oxidative stress by edaravone in ALS Amyotrophic Lateral Sclerosis (ALS)Edaravone treatment for ALS patientsOkayama universityNULLComplete: follow-up complete20years-old75years-oldMale and Female20Not applicableJapan
341NCT02936635
(ClinicalTrials.gov)
October 17, 201612/10/2016A Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)Amyotrophic Lateral Sclerosis (ALS)Drug: tirasemtivCytokineticsNULLCompleted18 YearsN/AAll280Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom
342NCT02868580
(ClinicalTrials.gov)
October 201616/6/2016Safety and Tolerability of Antiretroviral (Triumeq) in Patients With Amyotrophic Lateral Sclerosis (ALS).Phase 2a Open Label Study, Safety and Tolerability of Combination Antiretroviral Therapy (Triumeq) in Participants With Amyotrophic Lateral Sclerosis (ALS) - The Lighthouse Project.Amyotrophic Lateral SclerosisDrug: TriumeqNeuroscience Trials AustraliaMacquarie University, Australia;Westmead Hosptial;Calvary Health Care Bethlehem;The University of Sydney - Brain and Mind CentreCompleted18 Years75 YearsAll43Phase 2Australia
343NCT02781454
(ClinicalTrials.gov)
October 201610/5/2016Mexiletine in Sporadic Amyotrophic Lateral SclerosisEffect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)Sporadic Amyotrophic Lateral SclerosisDrug: Mexiletine;Drug: PlaceboUniversity of WashingtonMassachusetts General HospitalCompleted18 YearsN/AAll20Phase 2United States
344JPRN-UMIN000024312
2016/09/2025/05/2017Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds.Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. - Effect of febuxostat and inosine on CNS diseases Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosisTreatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeksTsukuba International Clinical Pharmacology ClinicNULLComplete: follow-up complete20years-old80years-oldMale and Female12Not selectedJapan
345NCT03067857
(ClinicalTrials.gov)
September 201625/2/2017Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron DiseaseAutologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron DiseaseMotor Neuron Disease;Amyotrophic Lateral Sclerosis;Primary Lateral Sclerosis;Progressive Muscular Atrophy;Progressive Bulbar PalsiesBiological: Stem CellsStem Cells ArabiaNULLUnknown status24 Years70 YearsAll40Phase 1/Phase 2NULL
346NCT02872142
(ClinicalTrials.gov)
August 29, 201611/8/2016Efficacy and Safety of Plasma Exchange With Albutein® 5% in Patients With Amyotrophic Lateral SclerosisPilot Study to Evaluate the Efficacy and Safety of Plasma Exchange With Albutein® 5% in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Albutein 5%Grifols Therapeutics LLCGrifols Biologicals, LLCCompleted19 Years69 YearsAll12Phase 2United States
347NCT02794857
(ClinicalTrials.gov)
August 29, 201624/5/2016Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic InflammationA Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) and Evidence of Elevated Systemic InflammationAmyotrophic Lateral SclerosisDrug: NP001;Drug: PlaceboNeuraltus Pharmaceuticals, Inc.NULLCompleted21 Years80 YearsAll138Phase 2United States;Canada
348EUCTR2015-005347-14-GB
(EUCTR)
25/08/201609/05/2016Efficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for controlling neuro-inflammation in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patientsEfficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for controlling neuro-inflammation in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patients:A randomized, double-blind, placebo- controlled, phase-II Proof of Concept/ Proof of Mechanism Clinical Trial - MIROCALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Proleukin 18 MUI
Product Name: proleukin
CHU DE NIMESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
216Phase 2United Kingdom
349EUCTR2015-004098-33-DE
(EUCTR)
16/08/201607/12/2015An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
183Phase 1;Phase 2;Phase 3United States;Japan;United Kingdom;Canada;Sweden;Belgium;Denmark;Korea, Republic of;Poland;Italy;Australia;France;Germany
350EUCTR2015-004098-33-SE
(EUCTR)
29/06/201627/11/2015An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
144Phase 1;Phase 2;Phase 3Belgium;United States;France;Canada;Denmark;Australia;Germany;United Kingdom;Japan;Italy;Sweden
351NCT03114215
(ClinicalTrials.gov)
June 29, 201628/3/2017Effect of MD1003 in Amyotrophic Lateral SclerosisEffect of MD1003 in Amyotrophic Lateral Sclerosis: a Randomized Double Blind Placebo Controlled Pilot StudyALS;Amyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: MD1003;Drug: Placebo oral capsuleMedDay Pharmaceuticals SANULLCompleted25 Years80 YearsAll30Phase 2France
352NCT03876002
(ClinicalTrials.gov)
June 28, 201613/3/2019Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06) PETEvaluation of Microglial Activation Using the PET Imaging Ligand [18F]PBR06 in Patients With Amyotrophic Lateral Sclerosis Compared to Healthy VolunteersHealthy Volunteers;Amyotrophic Lateral SclerosisDrug: [18F]PBR06Molecular NeuroImagingNULLCompleted18 Years80 YearsAll23Phase 1United States
353NCT03835507
(ClinicalTrials.gov)
June 20, 20168/8/2018Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral SclerosisRandomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: recombinant human erythropoietin(rhEPO)Hanyang University Seoul HospitalNULLRecruiting25 Years80 YearsAll64Phase 1/Phase 2Korea, Republic of
354EUCTR2015-005810-31-FR
(EUCTR)
03/06/201624/10/2016Effect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled studyEffect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled study - MD1003-ALS Amyotrophic lateral sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MD1003
INN or Proposed INN: BIOTIN
MEDDAY PHARMACEUTICALSNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
355NCT02655614
(ClinicalTrials.gov)
May 31, 20167/1/2016A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral SclerosisA Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Single- and Multiple-Ascending-Dose Study to Determine Initial Safety, Tolerability, and Pharmacokinetics of GDC-0134 in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: GDC-0134;Drug: Placebo;Drug: Rabeprazole;Drug: Midazolam;Drug: CaffeineGenentech, Inc.NULLCompleted18 YearsN/AAll54Phase 1United States;Canada;Netherlands
356EUCTR2014-005413-23-IT
(EUCTR)
30/05/201616/02/2018Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) - - Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
CYTOKINETICS, INC.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Italy
357EUCTR2014-005413-23-DE
(EUCTR)
20/05/201621/08/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
358NCT03241784
(ClinicalTrials.gov)
May 16, 201627/7/2017T-Regulatory Cells in Amyotrophic Lateral SclerosisExpansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis)Biological: Autologous T-regulatory lymphocytes;Biological: Interleukin-2Stanley H. Appel, MDNULLUnknown status18 YearsN/AAll4Phase 1United States
359EUCTR2014-005413-23-PT
(EUCTR)
09/05/201603/02/2016Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
360NCT02714036
(ClinicalTrials.gov)
May 6, 20169/3/2016A Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)A Multi-Center, Open-Label Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: ibudilastMediciNovaMassachusetts General Hospital;South Shore Neurologic AssociatesCompleted18 YearsN/AAll35Phase 1/Phase 2United States
361NCT04454840
(ClinicalTrials.gov)
May 1, 201629/6/2020Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral SclerosisA Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Plasma from healthy young people treatment + Riluzole;Drug: RiluzolePeking University Third HospitalNULLCompletedN/AN/AAll20Early Phase 1China
362NCT03204500
(ClinicalTrials.gov)
May 201628/6/2017Dual Treatment With Lithium and Valproate in ALS.A Randomized Clinical Trial, Double Blind, Placebo-controlled of Lithium and Valproate in Amyotrophic Lateral Sclerosis.Amyotrophic Lateral Sclerosis;Amyotrophic Lateral Sclerosis, SporadicCombination Product: Active treatment with dual therapy;Drug: PlacebosEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezNULLCompleted40 Years70 YearsAll43Phase 2Mexico
363EUCTR2014-005413-23-BE
(EUCTR)
20/04/201626/02/2016Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom
364EUCTR2015-004098-33-GB
(EUCTR)
18/04/201610/12/2015An Efficacy, Safety, Tolerability, Pharmacokinetics and PharmacodynamicsStudy of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics andPharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - Biogen 233AS101 Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 1;Phase 2;Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;Japan;Italy;United Kingdom;Korea, Republic of;Sweden
365EUCTR2014-005413-23-NL
(EUCTR)
06/04/201630/11/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom
366NCT02709330
(ClinicalTrials.gov)
April 20165/3/2016ALS Reversals - Lunasin RegimenAn Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)ALS (Amyotrophic Lateral Sclerosis)Drug: Lunasin Regimen;Other: Historical controlRichard Bedlack, M.D., Ph.D.NULLCompleted18 YearsN/AAll60Phase 2United States
367EUCTR2015-004098-33-BE
(EUCTR)
01/03/201614/01/2016An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB067 (ISIS666853)
Other descriptive name: BIIB067
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
144Phase 1;Phase 2;Phase 3United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Japan;Italy;Sweden
368EUCTR2014-005367-32-IT
(EUCTR)
29/02/201617/03/2017Clinical study on the efficacy and tolerabilty of Guabenz in Amiotropic Lateral SclerosisPROTEIN MISFOLDING, AMYOTROPHIC LATERAL SCLEROSIS AND GUANABENZ: A PHASE II RCT WITH FUTILITY DESIGN - PROMISE Amiotrophic Lateral Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GUANABENZ ACETATO
Product Code: GUANA2015
INN or Proposed INN: GUANABENZ
Other descriptive name: GUANABENZ
Product Name: RILUZOLO
INN or Proposed INN: RILUZOLO
Other descriptive name: RILUZOLO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Phase 2Italy
369EUCTR2014-005413-23-ES
(EUCTR)
09/02/201610/12/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
445Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom
370NCT02460679
(ClinicalTrials.gov)
January 14, 201621/5/2015Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)A Phase 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: EPI-589PTC TherapeuticsNULLCompleted21 Years70 YearsAll19Phase 2United States
371NCT04821479
(ClinicalTrials.gov)
January 1, 201619/10/2020Repeated Mesenchymal Stem Cell Injections in ALSSafety and Clinical Effects of Repeated Intrathecal Injections of Autologous Mesenchymal Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisBiological: Mesenchymal stem cells (MSC)Hadassah Medical OrganizationNULLCompleted18 Years65 YearsAll20Phase 1/Phase 2NULL
372EUCTR2014-005413-23-GB
(EUCTR)
01/12/201527/08/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
373ChiCTR-IPR-15007365
2015-11-042015-11-03A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral SclerosisA Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis amyotrophic lateral sclerosisTreatment group:to give Butylphthalide soft capsules, 2 / time, 3 times / day, fasting;Control group:to give placebo, 2 / time, 3 times / day, fasting;Peking Union Medical College HospitalNULLRecruitingBothTreatment group:147;Control group:147;China
374EUCTR2014-004567-21-NL
(EUCTR)
04/11/201504/08/2015Effects of ODM-109 on respiratory function in patients with ALS.Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength.
MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-109 capsule 1 mg
INN or Proposed INN: LEVOSIMENDAN
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Ireland;Germany;Netherlands;United Kingdom
375NCT02469896
(ClinicalTrials.gov)
November 20153/6/2015A Trial of Tocilizumab in ALS SubjectsA Phase 2 Randomized, Placebo Controlled Trial of Tocilizumab in ALS SubjectsALS;Amyotrophic Lateral Sclerosis;Lou Gehrig's Disease;Motor Neuron DiseaseDrug: Tocilizumab;Other: PlaceboBarrow Neurological InstituteALS Association;Barrow Neurological Foundation;Massachusetts General Hospital;Genentech, Inc.Completed18 Years75 YearsAll22Phase 2United States
376NCT02559869
(ClinicalTrials.gov)
November 201523/9/2015Imaging and BioFluid Biomarkers in Amyotrophic Lateral SclerosisImaging and BioFluid Biomarkers in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: [18F] GE-180Massachusetts General HospitalThe Methodist Hospital System;Cedars-Sinai Medical Center;ALS AssociationCompleted18 Years80 YearsAll86United States
377NCT03296501
(ClinicalTrials.gov)
October 13, 201521/9/2017Intraspinal Transplantation of Autologous ADRC in ALS PatientsSafety and Efficacy of Intraspinal Transplantation of Autologous ADRC in ALS PatientsAmyotrophic Lateral SclerosisBiological: Cell-based therapy of autologous adipose derived regenerative cells transplanted intraspinally and intrathecally in ALS patientsMossakowski Medical Research Centre Polish Academy of SciencesMedical University of WarsawActive, not recruiting18 Years65 YearsAll30Phase 1Poland
378JPRN-UMIN000019111
2015/10/0101/10/2015CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking.CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. - The sarcopenia improvement effect by Abound (TM) drinking against ALS Amyotrophic lateral sclerosisAbound(TM)
1,Take one pack twice a day in the moring and evening
2,Drinking was dissolved in water 240 ~ 300ml
3,Before meals, after meals does not matter
4,12 weeks
National Hospital Organization Takasaki General Medical CenterNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
379NCT02525471
(ClinicalTrials.gov)
October 201512/8/2015A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)ALSDrug: RNS60Sabrina Paganoni, M.D.NULLCompleted18 Years80 YearsAll24Phase 1United States
380EUCTR2014-004567-21-DE
(EUCTR)
22/09/201509/03/2015Effects of ODM-109 on respiratory function in patients with ALS.Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength.
MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-109 capsule 1 mg
INN or Proposed INN: LEVOSIMENDAN
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Ireland;Netherlands;Germany;United Kingdom
381EUCTR2010-024423-24-NL
(EUCTR)
21/09/201509/09/2015Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
382NCT02496767
(ClinicalTrials.gov)
September 3, 201510/7/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a YearA Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Tirasemtiv;Drug: Placebo tabletsCytokineticsNULLCompleted18 YearsN/AAll744Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom
383NCT02059759
(ClinicalTrials.gov)
September 20157/2/2014Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2Amyotrophic Lateral SclerosisDrug: Placebo;Drug: 1.0 MIU IL-2 per day;Drug: 2.0 MIU IL-2 per dayCentre Hospitalier Universitaire de NimesNULLCompleted18 Years75 YearsBoth36Phase 2France
384EUCTR2015-001431-20-NL
(EUCTR)
17/08/201521/04/2015Trial to look at the nerve conductance in patients with ALS, with and without Riluzole or Retigabine.A randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS. - Peripheral motor nerve excitability study in patients with ALS Amytrophic Lateral Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rilutek 50 mg film-coated tablets
Product Name: Rilutek
INN or Proposed INN: RILUZOLE
Trade Name: Trobalt
Product Name: Trobalt
INN or Proposed INN: RETIGABINE
Centre for Human Drug ResearchNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
385NCT02851914
(ClinicalTrials.gov)
July 21, 201528/7/2016SSRIs vs. TCAs for Depression in ALS PatientsAn Open-Label Pilot Study Comparing the Efficacy of Selective Serotonin Re-Uptake Inhibitors (SSRIs) Versus Tricyclic Antidepressants (TCAs) for Treating Depression in Amyotrophic Lateral SclerosisDepression;Amyotrophic Lateral SclerosisDrug: Tricyclic Antidepressants (TCA);Drug: Selective Serotonin Uptake Inhibitors (SSRI)St. Louis UniversityNULLCompleted25 Years80 YearsAll2Early Phase 1United States
386NCT02487407
(ClinicalTrials.gov)
July 20158/6/2015Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral SclerosisEffects of ODM-109 on Respiratory Function in Patients With ALS. A Randomized, Double Blind, Placebo-controlled, Cross-over, 3-period, Multicenter Study With Open-label Follow-up ExtensionAmyotrophic Lateral SclerosisDrug: ODM-109;Drug: Placebo for ODM-109Orion Corporation, Orion PharmaNULLCompleted18 YearsN/AAll66Phase 2Germany;Ireland;Netherlands;United Kingdom
387EUCTR2014-004567-21-IE
(EUCTR)
05/06/201505/03/2015Effects of ODM-109 on respiratory function in patients with ALS.Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength.
MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-109 capsule 1 mg
INN or Proposed INN: LEVOSIMENDAN
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Ireland;Netherlands;Germany;United Kingdom
388NCT02450552
(ClinicalTrials.gov)
June 201519/5/2015Clinical Trial of Ezogabine (Retigabine) in ALS SubjectsA Phase 2 Pharmacodynamic Trial of Ezogabine (Retigabine) on Neuronal Excitability in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Ezogabine;Drug: PlaceboBrian WaingerALS Association;GlaxoSmithKline;Harvard University;Massachusetts General HospitalCompleted18 Years80 YearsAll65Phase 2United States
389EUCTR2014-004567-21-GB
(EUCTR)
27/05/201510/03/2015Effects of ODM-109 on respiratory function in patients with ALS.Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength.
MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-109 capsule 1 mg
INN or Proposed INN: LEVOSIMENDAN
Orion Corporation Orion PharmaNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noIreland;Netherlands;Germany;United Kingdom
390EUCTR2010-024423-24-IT
(EUCTR)
05/05/201504/02/2014Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, di fase 2/3 sull'efficacia e la sicurezza di masitinib a confronto con placebo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA) - AB10015 patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 18.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib Mesylate
Other descriptive name: MASITINIB MESYLATE
INN or Proposed INN: Masitinib Mesylate
Other descriptive name: MASITINIB MESYLATE
AB SCIENCENULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3Romania;Netherlands;Germany;Portugal;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina
391NCT02116634
(ClinicalTrials.gov)
May 20156/4/2014Mesenchymal Stem Cell Injection in Amyotrophic Lateral SclerosisPhase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) PatientsAmyotrophic Lateral SclerosisBiological: mesenchymal stem cellAlzahra Hospital, IranNULLWithdrawn18 Years60 YearsBoth0Phase 1/Phase 2Iran, Islamic Republic of
392NCT02987413
(ClinicalTrials.gov)
April 28, 20151/7/2016Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis PatientsSafety and Efficacy of Mesenchymal Stem Cells Escalated Application in Amyotrophic Lateral Sclerosis Patients: Study Design of a Phase I TrialMotor Neuron DiseaseBiological: Autologous Mesenchymal stem cells (MSCs)Hospital e Maternidade Dr. Christóvão da GamaIEP São Lucas - Instituto de Ensino e Pesquisa;Clinica Jordy Sinapse;TECHLIFE - Centro de Tecnologia CelularCompleted18 YearsN/AAll3Phase 1Brazil
393EUCTR2010-024423-24-HU
(EUCTR)
21/04/201531/10/2014Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
300Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Germany;Netherlands
394EUCTR2010-024423-24-PT
(EUCTR)
10/04/201503/11/2014Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot Recruiting Female: yes
Male: yes
381 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
395NCT02463825
(ClinicalTrials.gov)
April 201521/4/2015A Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALSA Registry-Based Randomized-Controlled, Double-Blinded Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: Pimozide 2 mg per day;Drug: Pimozide 4 mg per day;Drug: Placebo (Lactose tablet)University of CalgaryHotchkiss Brain Institute, University of CalgaryActive, not recruiting18 YearsN/ABoth25Phase 2Canada
396EUCTR2010-024423-24-GR
(EUCTR)
06/03/201521/11/2013Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable Patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3United States;Portugal;Slovakia;Greece;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Netherlands;Germany
397NCT02405403
(ClinicalTrials.gov)
March 20152/3/2015Microglial Activation Role In ALS (MARIA)Microglial Activation Role In ALS (MARIA)Amyotrophic Lateral SclerosisDrug: [18F]DPA-714 PETUniversity Hospital, ToursNULLWithdrawn18 YearsN/AAll0Early Phase 1France
398JPRN-UMIN000016352
2015/02/0101/02/2015The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trialThe Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial - The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis amyotrophic lateral sclerosisedaravoneEhime University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Phase 1,2Japan
399NCT02306590
(ClinicalTrials.gov)
February 20151/12/2014Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDietary Supplement: Calogen;Dietary Supplement: PlaceboUniversity of UlmNULLCompleted18 YearsN/AAll207N/AGermany
400NCT02414230
(ClinicalTrials.gov)
February 20157/4/2015F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral SclerosisF 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis (IND 123119 Protocol B)Amyotrophic Lateral Sclerosis (ALS)Drug: Drug: F 18 T807Tammie L. S. Benzinger, MD, PhDNULLCompleted18 YearsN/AAll9United States
401NCT02269436
(ClinicalTrials.gov)
January 20158/10/2014A follow-on Study to Assess Long-term Safety and Tolerability of i.c.v Administration of sNN0029 in Patients With ALSA Multi-centre, Open-label, follow-on Study to Assess Long-term Safety and Tolerability of Intracerebroventricular Administration of sNN0029 in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: sNN0029 infusion solutionNewron Sweden ABNULLTerminated18 Years75 YearsBoth11Phase 1Belgium;Netherlands
402NCT02288091
(ClinicalTrials.gov)
January 20155/11/2014A Pilot Study of Inosine in Amyotrophic Lateral Sclerosis (ALS)A Pilot Study of Inosine in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: InosineMassachusetts General HospitalThe Salah Foundation;MGH cure ALS FundCompleted18 YearsN/AAll32Phase 1United States
403ChiCTR-IOR-14005674
2014-12-302014-12-09Open randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosisOpen randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosis amyotrophic lateral sclerosisChinese medicine :Jianpi Yifei Decoction ;Riluzole:Riluzole;Guangdong Province Traditional Chinese Medical HospitalNULLPending1880BothChinese medicine :30;Riluzole:30;China
404NCT02286011
(ClinicalTrials.gov)
November 201424/10/2014Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral SclerosisPhase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.ALS (Amyotrophic Lateral Sclerosis)Biological: MNC (Mononuclear cells);Other: SalineRed de Terapia CelularSpanish National Health System;Hospital Universitario Virgen de la Arrixaca;Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia;Public Health Service, Murcia;Instituto Murciano de Investigación Biosanitaria Virgen de la ArrixacaActive, not recruiting18 Years70 YearsAll20Phase 1Spain
405NCT02479802
(ClinicalTrials.gov)
November 201410/6/2015Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral SclerosisPilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: AlbuminInstituto Grifols, S.A.NULLCompleted18 Years70 YearsAll13Phase 2Spain
406JPRN-UMIN000015054
2014/09/2104/09/2014An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosisAn investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis - An investigator initiated clinical trial in healthy adults of WN1316 Amyotrophic Lateral Sclerosis (ALS)WN1316 solution 5mL is administered single dose orally.
The dosage of WN1316 is 60 micrograms in step 1, 180 micrograms in step 2, 600 micrograms in step 3.

Placebo (Distilled water) 5 mL is administered single dose orally.
Clinical Research Hospital TokyoNULLComplete: follow-up complete20years-old35years-oldMale24Not selectedJapan
407EUCTR2012-002099-15-SE
(EUCTR)
15/09/201401/08/2014Safety and Efficacy of Apovir for treatment of patients with ALS (Amyotrophic lateral sclerosis)A randomised, double blind, placebo controlled trial to evaluate the safety and efficacy of Apovir for treatment of patients with Amyotrophic lateral sclerosis Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pleconaril
Product Code: APO-P001
INN or Proposed INN: PLECONARIL
Trade Name: Copegus
Product Name: Ribavirin
Other descriptive name: RIBAVIRIN
Apodemus ABNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
408EUCTR2014-002228-28-IT
(EUCTR)
01/09/201412/06/2014STEMALS-IIA double blind, placebo controlled, parallel groups, multicenter study on filgrastim in amyotrophic lateral sclerosis - STEMALS-II Amyotrophic lateral sclerosis (ALS) is a severe progressive neurological disorder characterized by a selective degeneration of spinal, bulbar, and cortical motor neurons.;Therapeutic area: Not possible to specifyTrade Name: TEVAGRASTIM
Product Name: filgrastim
Trade Name: MANNITOLO 18% LDB
Product Name: MANNITOLO 18%
Trade Name: PERFALGAN
Product Name: PARACETAMOLO
Università degli Studi di Torino e Azienda Ospedaliera Città della Salute e della Scienza di TorinoNULLNot RecruitingFemale: yes
Male: yes
90Phase 2Italy
409NCT01999803
(ClinicalTrials.gov)
September 201422/11/2013A Safety Study of sNN0029 Administration Via Intracerebroventricular Route to Patients With ALSA Phase I, Randomised, Double-blind, Placebo-controlled Study in Patients With Amyotrophic Lateral Sclerosis to Further Assess the Safety and Tolerability of Intracerebroventricular Administration of sNN0029 Infusion SolutionAmyotrophic Lateral SclerosisDrug: sNN0029;Drug: PlaceboNewron Sweden ABNULLTerminated18 Years75 YearsBoth15Phase 1Belgium;Netherlands
410NCT02238626
(ClinicalTrials.gov)
September 20144/9/2014Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Single-center, Randomized, Double-blind, Placebo-controlled, 6-month Trial Followed by an Open-label Extension to Evaluate the Safety, Tolerability and Clinical Endpoint Responsiveness of Ibudilast (MN-166) in Subjects With (ALS)Amyotrophic Lateral SclerosisDrug: Placebo (for MN-166);Drug: MN-166;Drug: riluzoleMediciNovaAtrium HealthCompleted18 Years80 YearsAll71Phase 2United States
411NCT02492516
(ClinicalTrials.gov)
September 201424/6/2015Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALSEvaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALSAmyotrophic Lateral SclerosisBiological: mesenchymal stem cellsRoyan InstituteNULLCompleted18 Years55 YearsAll19Phase 1Iran, Islamic Republic of
412NCT02236065
(ClinicalTrials.gov)
August 20148/9/2014Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative DisordersA Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative DisordersBrain Injury;Cerebral Palsy;Amyotrophic Lateral Sclerosis;Parkinson's DiseaseProcedure: Umbilical cord blood therapy;Biological: FilgrastimMinYoung Kim, M.D.NULLCompleted19 Years75 YearsAll10N/AKorea, Republic of
413EUCTR2011-004801-25-ES
(EUCTR)
16/07/201411/01/2013CLINICAL TRIAL ON THE USE OF BONE MARROW OWN PATIENT'S WITH AMYOTROPHIC LATERAL SCLEROSISA PHASE I/II CLINICAL TRIAL OF THE BONE MARROW'S AUTOLOGOUS STEM CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS amyotrophic lateral sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: células troncales hematopoyéticas autólogas adultas extraidas de médula ósea
INN or Proposed INN: autologous bone marrow mononucleated cells
Other descriptive name: autologous bone marrow mononucleated cells
Fundación Sanitaria para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 1/2Spain
414NCT02152449
(ClinicalTrials.gov)
July 201428/5/2014Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) PatientsImpact on Functional Status of Early Oral Nutritional Supplementation (ONS) in Amyotrophic Lateral Sclerosis (ALS) PatientsAmyotrophic Lateral Sclerosis (ALS)Dietary Supplement: Oral nutritional supplementationUniversity Hospital, LimogesLaboratoires NUTRICIACompleted18 YearsN/AAll229N/AFrance
415NCT02290886
(ClinicalTrials.gov)
July 20149/10/2014A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis LateralA Multicenter Phase I/II Clinical Trial, Randomized, Controlled With Placebo, Triple Blind to Evaluate Safety, and Indications of Efficiency of the Intravenous Administration of the Therapy With 3 Doses of MSC in Patients With ASL Moderated to SevereAmyotrophic Lateral SclerosisOther: Intravenous administration of placebo;Drug: Intravenous administration of 1 million of MSC;Drug: Intravenous administration of 2 million of MSC;Drug: Intravenous administration of 4 million of MSCAndalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludIniciativa Andaluza en Terapias AvanzadasCompleted18 YearsN/AAll52Phase 1/Phase 2Spain
416NCT03367650
(ClinicalTrials.gov)
May 13, 201428/11/2017Epidemiology and Genetics of the Amyotrophic Lateral Sclerosis in the French West IndiesEpidemiology and Genetics of the Amyotrophic Lateral Sclerosis in the French West IndiesAmyotrophic Lateral SclerosisDietary Supplement: Blood sample and environmental surveyCentre Hospitalier Universitaire de Pointe-a-PitreNULLRecruiting18 YearsN/AAll70N/AGuadeloupe;Martinique
417EUCTR2013-004842-40-ES
(EUCTR)
09/05/201407/03/2014Pilot study to evaluate the effect of plasma exchange with albumin in patients with amyotrophic lateral sclerosisPilot study to evaluate the effect of plasma exchange in motor and cognitive function in patients with amyotrophic lateral sclerosis - Albumin in ALS Amytrophic Lateral Sclerosis (ALS)
MedDRA version: 16.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Albutein 5%
INN or Proposed INN: albúmina humana
Other descriptive name: HUMAN ALBUMIN SOLUTION
Instituto Grifols S.A.NULLNot RecruitingFemale: yes
Male: yes
Phase 4Spain
418NCT02017912
(ClinicalTrials.gov)
May 201417/12/2013Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALSA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate Safety and Efficacy of Transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (MSC-NTF) in Patients With ALSAmyotrophic Lateral Sclerosis (ALS)Biological: Autologous MSC-NTF cells;Biological: PlaceboBrainstorm-Cell TherapeuticsNULLCompleted18 Years75 YearsAll48Phase 2United States
419EUCTR2010-024423-24-SK
(EUCTR)
07/04/201405/12/2013Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
420NCT02166944
(ClinicalTrials.gov)
April 20149/6/2014Tamoxifen Treatment in Patients With Motor Neuron DiseaseThe Study of Tamoxifen Treatment in Patients With Motor Neuron DiseaseAmyotrophic Lateral Sclerosis;ALS Functional Ration Scale;TAR-DNA-binding Protein-43;Tamoxifen;mTORDrug: tamoxifen 40 mg daily for one yearTaipei Medical University Shuang Ho HospitalNULLCompleted20 Years80 YearsAll20Phase 1/Phase 2Taiwan
421NCT01759784
(ClinicalTrials.gov)
March 201429/12/2012Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALSSafety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALSAmyotrophic Lateral SclerosisBiological: Intraventricular injectionRoyan InstituteNULLWithdrawn18 Years70 YearsBoth0Phase 1Iran, Islamic Republic of
422NCT02039401
(ClinicalTrials.gov)
February 201415/1/2014Safety Study of VM202 to Treat Amyotrophic Lateral SclerosisA Phase I/II, Open Label Study to Assess the Safety and Tolerability of VM202 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: VM202Helixmith Co., Ltd.NULLCompleted21 Years75 YearsAll18Phase 1/Phase 2United States
423NCT02645461
(ClinicalTrials.gov)
January 201422/12/2015Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALSAcetylcholine Receptors From Human Muscles as Pharmacological Target for ALSAmyotrophic Lateral SclerosisDrug: endocannabinoid palmitoylethanolamide (PEA);Drug: RiluzoleUniversity of Roma La SapienzaNULLCompleted18 YearsN/ABoth50N/ANULL
424NCT01786603
(ClinicalTrials.gov)
November 21, 201328/11/2012Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: Rasagiline;Drug: PlaceboRichard Barohn, MDNULLCompleted21 Years80 YearsAll80Phase 2United States
425NCT01884571
(ClinicalTrials.gov)
October 201319/6/2013Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Basiliximab;Drug: Methylprednisolone;Drug: Prednisone;Drug: Tacrolimus;Drug: Mycophenolate mofetilEmory UniversityALS AssociationCompleted18 YearsN/AAll31Phase 2United States
426JPRN-UMIN000011494
2013/09/0202/09/2013Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' droolingAssessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling - SCOPOLA-D amyotrophic lateral sclerosisscopolamine patch 7days-washout 7days-placebo patch 7days
placebo patch 7days-washout 7days-scopolamine patch 7days
Mie University Graduate school of medicine,Department of neurologyMatsusaka Chuou HospitalNational Mie HospitalComplete: follow-up completeNot applicableNot applicableMale and Female10Not applicableJapan
427NCT02164253
(ClinicalTrials.gov)
September 201320/5/2014Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) PatientsFeasibility and Safety Pilot Therapeutic Study of the Iron Chelator Deferiprone in Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis);Iron OverloadDrug: DeferiproneUniversity Hospital, LilleApoPharmaCompleted18 Years85 YearsAll23Phase 2France
428NCT01935518
(ClinicalTrials.gov)
September 20131/9/2013A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Historical Placebo Controlled Screening Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: FasudilPeking University Third HospitalNULLRecruiting18 Years70 YearsBoth10Phase 2China
429NCT01771640
(ClinicalTrials.gov)
August 201316/1/2013Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALSIntrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALSAmyotrophic Lateral SclerosisBiological: intrathecal injectionRoyan InstituteNULLCompleted18 Years65 YearsAll8Phase 1Iran, Islamic Republic of
430NCT01854294
(ClinicalTrials.gov)
August 20138/5/2013GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)Amyotrophic Lateral SclerosisDrug: GM604;Drug: Placebo comparatorGenervon Biopharmaceuticals, LLCColumbia University;Massachusetts General HospitalCompleted18 YearsN/AAll12Phase 2United States
431NCT01786174
(ClinicalTrials.gov)
August 20134/2/2013Gilenya in Amyotrophic Lateral Sclerosis (ALS)Phase IIa Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Oral Fingolimod in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Gilenya;Other: PlaceboMassachusetts General HospitalALS Therapy Development InstituteCompleted18 YearsN/AAll30Phase 2United States
432NCT01906658
(ClinicalTrials.gov)
July 201315/7/2013A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral SclerosisA Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Repository corticotropin injectionMallinckrodtNULLCompleted18 Years80 YearsAll43Phase 2United States
433NCT01849770
(ClinicalTrials.gov)
July 20136/5/2013Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)A Safety and Tolerability Study of Mexiletine in Patients With Sporadic Amyotrophic Lateral Sclerosis (SALS)Sporadic Amyotrophic Lateral SclerosisDrug: Mexiletine;Drug: PlaceboUniversity of WashingtonNULLCompleted18 YearsN/AAll75Phase 2United States
434EUCTR2012-004987-23-ES
(EUCTR)
12/06/201316/05/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;France;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
435NCT01879241
(ClinicalTrials.gov)
June 201312/6/2013Study of Rasagiline in Patients With Amyotrophic Lateral SclerosisEfficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized SubstanceAmyotrophic Lateral SclerosisDrug: Rasagiline;Drug: PlaceboUniversity of UlmNULLCompleted18 YearsN/ABoth252Phase 2Germany
436NCT01811355
(ClinicalTrials.gov)
May 20136/3/2013Mexiletine for the Treatment of Muscle Cramps in ALSMexiletine for the Treatment of Muscle Cramps in ALSMuscle Cramps in Amyotrophic Lateral SclerosisDrug: Mexiletine;Drug: PlaceboBjorn Oskarsson, MDUniversity of California, Davis;ALS AssociationCompleted21 Years89 YearsAll23Phase 4United States
437EUCTR2012-004987-23-DE
(EUCTR)
29/04/201317/01/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
438EUCTR2011-004482-32-DE
(EUCTR)
10/04/201321/12/2012Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - RAS-ALS Trial Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: AZILECT® 1 mg Tabletten
INN or Proposed INN: Rasagiline Mesilate
Other descriptive name: RASAGILINE MESILATE
Universitätsklinikum UlmNULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany
439NCT02588677
(ClinicalTrials.gov)
April 201320/10/2015Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of MasitinibAmyotrophic Lateral Sclerosis (ALS)Drug: Masitinib (4.5);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (3.0)AB ScienceNULLCompleted18 YearsN/AAll394Phase 2/Phase 3Spain
440NCT01806857
(ClinicalTrials.gov)
April 20135/3/2013Clinical Trial Nuedexta in Subjects With ALSThe Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Nuedexta;Drug: Matching PlaceboCenter for Neurologic Study, La Jolla, California,ALS Association;State University of New York - Upstate Medical UniversityCompleted18 YearsN/AAll90Phase 2United States
441EUCTR2011-004798-99-DE
(EUCTR)
27/02/201327/12/2012Safety and Efficacy of SOD1 Inhibition By Pyrimethamine in Familial (ALS)Safety and Efficacy of SOD1 Inhibition By Pyrimethamine in Familial (ALS) - Pyrimethamine In Familial ALS Familial amyotrophic lateral sclerosis (FALS)
MedDRA version: 14.1;Level: LLT;Classification code 10036704;Term: Primary lateral sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Daraprim
INN or Proposed INN: PYRIMETHAMINE
Weill Medical College of Cornell UniversityNULLNot RecruitingFemale: yes
Male: yes
40United States;Germany;Italy
442EUCTR2011-006254-85-ES
(EUCTR)
08/02/201309/08/2012Clinical trial to value the safety and efficacy of administration of stem cells derived from own patient for the treatment of Amyotrophic Lateral Sclerosis (ALS).Placebo controlled, randomized and triple blind multicentric phase I/II clinical trial to evaluate the safety, feasibility and valoration of efficacy trends of intravenous administration of three doses of autologous adipose derived autologous mesenchymal stem cells (CeTMAd) in moderate/severe ALS patients. Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Células madre mesenquimales de tejido adiposo autólogo
INN or Proposed INN: NA
Other descriptive name: Células Mesenquimales de tejido adiposo
FUNDACIÓN PROGRESO Y SALUDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 1/2Spain
443EUCTR2012-004987-23-IE
(EUCTR)
08/02/201330/11/2012A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
444EUCTR2010-024423-24-ES
(EUCTR)
29/01/201329/11/2012Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: MASITINIB
ABScienceNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy
445EUCTR2012-004987-23-GB
(EUCTR)
24/01/201312/12/2012A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
446EUCTR2012-003349-13-DE
(EUCTR)
15/01/201312/12/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS)Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
294Phase 2France;United States;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;Italy;Japan;Korea, Republic of
447EUCTR2012-003349-13-NL
(EUCTR)
15/01/201312/11/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS)Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
294Phase 2France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Japan;Korea, Republic of
448NCT01776970
(ClinicalTrials.gov)
January 201324/1/2013Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron DiseaseA Fase II, Randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease PatientsMotor Neuron Disease;Amyotrophic Lateral Sclerosis (ALS)Drug: Cannabis Sativa extract Oromucosal sprayOspedale San RaffaeleFondazione Salvatore Maugeri;Niguarda Hospital;University of PadovaCompleted18 Years80 YearsAll60Phase 2/Phase 3Italy
449NCT01835782
(ClinicalTrials.gov)
January 201327/3/2013Determining the Safety of L-serine in ALSDetermining the Safety of L-Serine in Subjects With Amyotrophic Lateral Sclerois (ALS) at Varied Doses.Amyotrophic Lateral Sclerosis (ALS)Drug: L-SerinePhoenix Neurological Associates, LTDInstitute for EthnomedicineActive, not recruiting18 Years85 YearsBoth20Phase 1/Phase 2United States
450NCT01759797
(ClinicalTrials.gov)
January 201331/12/2012Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALSSafety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALSAmyotrophic Lateral SclerosisBiological: intra venous injection of stem cellRoyan InstituteNULLCompleted18 Years65 YearsBoth6Phase 1Iran, Islamic Republic of
451EUCTR2012-003349-13-GB
(EUCTR)
19/12/201218/12/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
294 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Australia;Germany;Netherlands;Italy;Japan;United Kingdom;Korea, Republic of
452EUCTR2012-003349-13-FR
(EUCTR)
17/12/201220/06/2013A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
294 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Japan;Korea, Republic of
453EUCTR2012-003349-13-BE
(EUCTR)
06/12/201202/10/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS)Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 15.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
294Phase 2Australia;Germany;Netherlands;United Kingdom;France;United States;Canada;Belgium;Italy;Japan;Korea, Republic of
454EUCTR2012-003349-13-IT
(EUCTR)
03/12/201211/12/2012a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral SclerosisStudy NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
294Phase 2France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Japan;Italy;Korea, Republic of
455NCT01753076
(ClinicalTrials.gov)
December 1, 201217/12/2012Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral SclerosisStudy NOG112264, a Phase II Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Ozanezumab;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years80 YearsAll304Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;United Kingdom
456NCT01777646
(ClinicalTrials.gov)
December 201212/12/2012Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS).Amyotrophic Lateral SclerosisBiological: MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSFBrainstorm-Cell TherapeuticsHadassah Medical OrganizationCompleted20 Years75 YearsAll14Phase 2Israel
457NCT01758510
(ClinicalTrials.gov)
December 201210/12/2012Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral SclerosisAn Open-label, Phase 1 Trial for Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell(HYNR-CS-Allo Inj) Treatment in Amyotrophic Lateral Sclerosis(ALS)Amyotrophic Lateral Sclerosis;Motor Neuron Disease;Neuromuscular Disease;Neurodegenerative Disease;Central Nervous System DiseaseGenetic: HYNR-CS-AlloHanyang University Seoul HospitalCorestem, Inc.Completed25 Years80 YearsAll6Phase 1Korea, Republic of
458NCT01825551
(ClinicalTrials.gov)
November 201213/3/2013The Effect of GCSF in the Treatment of ALS PatientsThe Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013Amyotrophic Lateral SclerosisDrug: Granulocyte Colony Stimulating Factor;Drug: PlaceboTehran University of Medical SciencesNULLCompleted18 Years85 YearsBoth40Phase 2/Phase 3Iran, Islamic Republic of
459NCT01709149
(ClinicalTrials.gov)
October 201216/10/2012Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS)Amyotrophic Lateral SclerosisDrug: CK-2017357;Other: Placebo tablets;Drug: RiluzoleCytokineticsNULLCompleted18 YearsN/AAll711Phase 2United States;Canada;France;Germany;Ireland;Netherlands;Spain;United Kingdom
460NCT01160263
(ClinicalTrials.gov)
October 20129/7/2010Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and ControlsStudy of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECTAmyotrophic Lateral SclerosisDrug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAMAssistance Publique - Hôpitaux de ParisAssociation Française contre les Myopathies (AFM), Paris;ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique);AGEPSCompleted39 Years66 YearsBoth16Phase 3France
461NCT01933321
(ClinicalTrials.gov)
September 201228/9/2012Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisBiological: Intrathecal autologous stem cellHospital Universitario Dr. Jose E. GonzalezNULLCompleted18 YearsN/ABoth14Phase 2/Phase 3Mexico
462EUCTR2011-006119-70-DE
(EUCTR)
31/08/201220/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
463EUCTR2011-006119-70-NL
(EUCTR)
30/08/201214/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
464EUCTR2011-006119-70-BE
(EUCTR)
13/08/201214/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Canada;Spain;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
465EUCTR2011-006119-70-GB
(EUCTR)
10/08/201218/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
466EUCTR2011-006119-70-IE
(EUCTR)
03/08/201207/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
467EUCTR2011-006119-70-ES
(EUCTR)
27/07/201211/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
468NCT01622088
(ClinicalTrials.gov)
June 20123/5/2012Phase 3 Extension Study of Dexpramipexole in ALSAn Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: DexpramipexoleKnopp BiosciencesBiogenTerminated18 Years80 YearsAll616Phase 3United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom
469EUCTR2011-006119-70-SE
(EUCTR)
15/05/201219/04/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
470NCT01609283
(ClinicalTrials.gov)
May 201218/5/2012A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral SclerosisA Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: autologous mesenchymal stem cellsMayo ClinicNULLCompleted18 YearsN/AAll27Phase 1United States
471EUCTR2011-000362-35-CZ
(EUCTR)
29/03/201205/04/2011Safety and Efficacy of Stem Cell Therapy of Motor Neuron Disease.A Prospective, Non-randomized, Open Label Study to Assess the Safety and the Efficacy of Autologous Multipotent Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis. - AMSC in ALS Amyotrophic lateral sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Suspension of human autologous MSC 3P in 1,5 ml
Product Code: AMSC
INN or Proposed INN: Human autologous mesenchymal stem cells
Bioinova, s.r.o.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Czech Republic
472NCT01536249
(ClinicalTrials.gov)
March 201216/2/2012Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy VolunteersAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: Cimetidine plus DexpramipexoleKnopp BiosciencesNULLCompleted18 Years55 YearsBoth14Phase 1United States
473NCT01565395
(ClinicalTrials.gov)
March 201226/3/2012Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Parkinson Disease;Amyotrophic Lateral SclerosisDrug: Incobotulinum Toxin A;Drug: placeboBeth Israel Deaconess Medical CenterMerz PharmaceuticalsWithdrawn20 Years80 YearsAll0Phase 2United States
474NCT01551940
(ClinicalTrials.gov)
February 20129/3/2012Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related SialorrheaEvaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)Sialorrhea;Amyotrophic Lateral SclerosisDrug: Botox injection;Drug: Placebo injectionHospices Civils de LyonNULLCompleted18 YearsN/ABoth18Phase 2France
475NCT03828123
(ClinicalTrials.gov)
January 201220/7/2017Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral SclerosisA Prospective, Non-randomized, Open Label Study to Assess the Safety and the Efficacy of Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral SclerosisMotor Neuron Disease, Amyotrophic Lateral SclerosisBiological: Suspension of human autologous MSC 3P in 1.5 mlBioinova, s.r.o.Department of Neurology, University Hospital Motol, Prague, Czech RepublicCompleted18 Years65 YearsAll26Phase 1/Phase 2NULL
476NCT01511029
(ClinicalTrials.gov)
January 20129/1/2012Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate)A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy VolunteersAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: Dexpramipexole Placebo;Drug: MoxifloxacinKnopp BiosciencesNULLCompleted18 Years60 YearsBoth68Phase 1United States
477NCT01492686
(ClinicalTrials.gov)
December 201111/12/2011Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral SclerosisEfficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2Amyotrophic Lateral Sclerosis (ALS)Drug: MCI-186;Drug: Placebo;Drug: MCI-186 in open label phaseMitsubishi Tanabe Pharma CorporationNULLCompleted20 Years75 YearsAll137Phase 3Japan
478NCT01232738
(ClinicalTrials.gov)
December 201122/10/2010Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: rasagilineYunxia Wang, MDWestern ALS Study GroupCompleted21 Years80 YearsAll36Phase 2United States;Canada
479NCT01640067
(ClinicalTrials.gov)
December 20119/7/2012Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)Intra-spinal Cord Delivery of Human Neural Stem Cells in ALS Patients: Proposal for a Phase I Study/ Trapianto Intramidollare di Cellule Staminali Neurali Umane Come Terapia Putativa Per la SLA: Proposta di un Trial Clinico di Fase IAmyotrophic Lateral SclerosisBiological: Human Neural Stem CellsAzienda Ospedaliera Santa Maria, Terni, ItalyAzienda Ospedaliero Universitaria Maggiore della Carita;Università di Padova ItalyCompleted20 Years75 YearsBoth18Phase 1Italy
480EUCTR2010-023161-21-FR
(EUCTR)
23/11/201106/09/2011Sclérose Latérale Amyotrophique (SLA) – toxine botulinique A (Botox®)Evaluation de la toxine botulinique dans le traitement du trouble salivaire chez le patient atteint de sclérose latérale amyotrophique - SLA-TOX Sclérose Latérale Amyotrophique (SLA)
MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BOTOX 100 UNITES ALLERGAN (PR1)
Other descriptive name: BOTULINUM TOXIN TYPE A
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2France
481NCT01486849
(ClinicalTrials.gov)
November 201123/11/2011Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose Titration Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: CK-2017357;Drug: Placebo;Drug: Riluzole 50 MGCytokineticsNULLCompleted18 YearsN/AAll27Phase 2United States
482NCT01449578
(ClinicalTrials.gov)
November 201122/9/2011Dexpramipexole SAD/MAD StudyA Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy VolunteersAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: Dexpramipexole PlaceboKnopp BiosciencesNULLCompleted18 Years55 YearsBoth63Phase 1United States
483JPRN-UMIN000006423
2011/10/0101/10/2011The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosisThe clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis - Mexiletine on amyotrophic lateral sclerosis amyotrophic lateral sclerosisadministration of mexiletine and riluzole
administration of riluzole only
Department of Neurology, Graduate School of Medicine, Chiba University, Japan.NULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not selectedJapan
484EUCTR2011-001329-26-IT
(EUCTR)
03/08/201117/11/2011Erythropoietin in Amyotrophic Lateral Sclerosis: a study to identify the best dose and the optimal route of administration and evaluate the safetyErythroPOietin in ALS: a Study of dose-finding and Safety - EPOSS2010 Amyotrophic Lateral Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: EPREX*1SIR 40000UI/ML 1ML
INN or Proposed INN: ERYTHROPOIETIN
ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Italy
485NCT01424163
(ClinicalTrials.gov)
August 201128/7/2011Dexpramipexole Japanese PK StudyA Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian SubjectsAmyotrophic Lateral SclerosisDrug: Single dose reduced;Drug: Single dose standard;Drug: Multiple DoseKnopp BiosciencesBiogenCompleted18 Years60 YearsAll57Phase 1United Kingdom
486NCT01424176
(ClinicalTrials.gov)
July 201123/6/2011Dexpramipexole Renal PK StudyA Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal ImpairmentAmyotrophic Lateral Sclerosis;Renal InsufficiencyDrug: Dexpramipexole (dose 1);Drug: Dexpramipexole (dose 2)Knopp BiosciencesNULLCompleted18 Years75 YearsBoth36Phase 1United States
487EUCTR2010-022818-19-ES
(EUCTR)
09/06/201121/02/2011A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Dexpramipexol en sujetos con Esclerosis Lateral Amiotrófica - EMPOWERA randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Dexpramipexol en sujetos con Esclerosis Lateral Amiotrófica - EMPOWER Amyotrophic lateral sclerosis (ALS)Esclerosis lateral amiotrófica (ELA)
MedDRA version: 12.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: (6R)-4, 5, 6, 7 - tetrahydro-N6-propyl-2,6-benzothiazolidiamine dihydrochloride monohydrate
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
804Phase 3Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Sweden
488EUCTR2010-022818-19-BE
(EUCTR)
07/06/201124/01/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915Phase 3United States;Canada;Spain;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
489NCT01051882
(ClinicalTrials.gov)
June 201117/1/2010Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.A Phase I/II, Open Label Study to Evaluate Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.Amyotrophic Lateral SclerosisBiological: MSC-NTF cells transplantation (IM);Biological: MSC-NTF cells transplantation (IT)Brainstorm-Cell TherapeuticsHadassah Medical OrganizationCompleted20 Years75 YearsAll12Phase 1/Phase 2Israel
490NCT01378676
(ClinicalTrials.gov)
June 201120/6/2011A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Placebo (Part A);Drug: CK-2017357 (Part A);Drug: Riluzole 50 MG (Part B);Drug: Placebo (Part B);Drug: CK-2017357 (Part B)CytokineticsNULLCompleted18 YearsN/AAll49Phase 2United States
491EUCTR2010-022818-19-NL
(EUCTR)
24/05/201111/05/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
492EUCTR2010-022818-19-DE
(EUCTR)
12/05/201121/02/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dihydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
493EUCTR2010-021179-10-GB
(EUCTR)
18/04/201131/01/2011An Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzoleAn Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzole Disease under investigation : Amyotrophic lateral Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: Olesoxime
Other descriptive name: 4 cholesten-3-one, oxime
TROPHOSNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Spain
494EUCTR2010-022818-19-IE
(EUCTR)
08/04/201115/02/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 15.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
495EUCTR2010-022818-19-SE
(EUCTR)
07/04/201109/02/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden;United States;Canada
496EUCTR2010-022818-19-GB
(EUCTR)
22/03/201110/01/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
497EUCTR2010-021179-10-DE
(EUCTR)
15/03/201112/11/2010An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. Amyotrophic Lateral Sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS
Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
Spain;Germany;United Kingdom
498NCT01281189
(ClinicalTrials.gov)
March 201120/1/2011Phase 3 Study of Dexpramipexole in ALSA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: PlaceboKnopp BiosciencesNULLCompleted18 Years80 YearsAll943Phase 3United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom
499NCT00876772
(ClinicalTrials.gov)
March 20116/4/2009Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)Randomized, Placebo-controlled Parallel Group Study for the Evaluation of an Oral Dose of 10mg Olanzapine in Combination With Riluzole for the Treatment of Loss of Appetite in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: OlanzapineCharite University, Berlin, GermanyNULLRecruiting18 Years80 YearsBoth40Phase 2/Phase 3Germany
500NCT01257581
(ClinicalTrials.gov)
March 20118/12/2010Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Phase 2 Selection Trial of High Dosage Creatine and Two Dosages of Tamoxifen in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: creatine;Drug: tamoxifenNazem AtassiALS Therapy Alliance;State University of New York - Upstate Medical UniversityCompleted18 YearsN/AAll60Phase 2United States
501NCT01281631
(ClinicalTrials.gov)
February 201117/1/2011A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: NP001;Drug: PlaceboNeuraltus Pharmaceuticals, Inc.NULLCompleted21 Years80 YearsBoth136Phase 2United States
502NCT01363401
(ClinicalTrials.gov)
February 201130/5/2011Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral SclerosisAn Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;ALSBiological: HYNR-CS inj;Other: Control groupCorestem, Inc.NULLCompleted25 Years75 YearsAll72Phase 1/Phase 2Korea, Republic of
503NCT02880033
(ClinicalTrials.gov)
February 20113/8/2016Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating LymphocytesModulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral SclerosisParkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron OverloadDrug: deferiprone;Drug: placeboUniversity Hospital, LilleNULLCompleted18 Years80 YearsAll90N/AFrance
504NCT01277315
(ClinicalTrials.gov)
February 201113/1/2011Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral SclerosisOpen Safety and Tolerability Trial to Evaluate a Subcutaneous Injection Solution of 100 mg of Anakinra in Combination With Riluzol in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: AnakinraCharite University, Berlin, GermanyMax Planck Institute for Infection BiologyRecruiting18 Years80 YearsBoth20Phase 2Germany
505EUCTR2010-021179-10-BE
(EUCTR)
28/01/201105/01/2011An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. Amyotrophic Lateral Sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS
Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
Phase 2;Phase 3Spain;Belgium;Germany;United Kingdom
506EUCTR2010-022808-40-IT
(EUCTR)
13/01/201102/02/2011A fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - NDA fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - ND amyotrophic lateral sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10002026
Trade Name: sativex
INN or Proposed INN: sativex
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABORNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
507NCT03085706
(ClinicalTrials.gov)
October 201015/3/2017Transplantation of Autologous Peripheral Blood Mononuclear Cells for Amyotrophic Lateral SclerosisTransplantation of Autologous Peripheral Blood Mononuclear Cells in the Subarachnoid Space for Amyotrophic Lateral Sclerosis: a Safety Analysis of 14 PatientsAmyotrophic Lateral SclerosisBiological: PBMC autotransplantationThe First Affiliated Hospital of Dalian Medical UniversityNULLCompleted31 Years75 YearsAll14N/AChina
508NCT01259050
(ClinicalTrials.gov)
October 201010/12/2010Safety Study of High Doses of Zinc in ALS PatientsPhase 1 Open Label Study of Zinc Therapy in ALS PatientsAmyotrophic Lateral SclerosisDrug: Zinc and CopperPhoenix Neurological Associates, LTDNULLCompleted18 Years85 YearsBoth10Phase 1/Phase 2United States
509NCT01285583
(ClinicalTrials.gov)
October 201026/1/2011Safety Extension Study of TRO19622 in ALSAn Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With RiluzoleAmyotrophic Lateral SclerosisDrug: TRO19622Hoffmann-La RocheNULLCompletedN/AN/ABoth271Phase 2/Phase 3Belgium;France;Germany;Spain;United Kingdom
510EUCTR2010-020257-13-IT
(EUCTR)
30/07/201005/07/2010A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALSA pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1;Level: SOC;Classification code 10029205
Trade Name: MYONAL*30CPR RIV 100MG
INN or Proposed INN: EPERISONE
Trade Name: LIORESAL*50CPR 10MG
INN or Proposed INN: Baclofen
AZIENDA OSPEDALIERO-UNIVERSITARIANULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy
511NCT01091142
(ClinicalTrials.gov)
July 201019/3/2010Single-Ascending-Dose Safety/Tolerability of NP001 in Amyotrophic Lateral Sclerosis (ALS)Single-Ascending-Dose Safety and Tolerability Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: NP001;Drug: PlaceboNeuraltus Pharmaceuticals, Inc.NULLCompleted21 Years75 YearsBoth56Phase 1United States
512EUCTR2008-003982-21-FR
(EUCTR)
10/06/201014/01/2010Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALSEtude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALS Patients présentant une SLA et volontaires sains
MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: DaTSCAN
Product Name: Datscan
INN or Proposed INN: Ioflupane 123I
Product Name: [I-123] ADAM
INN or Proposed INN: [I-123] ADAM
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
France
513NCT01142856
(ClinicalTrials.gov)
June 201010/6/2010Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisBiological: autologous mesenchymal stem cellsMayo ClinicNULLCompleted18 YearsN/ABoth1Phase 1United States
514EUCTR2009-016066-91-IT
(EUCTR)
10/03/201017/11/2009SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - NDSAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - ND ALS
MedDRA version: 9.1;Level: SOC;Classification code 10029205
Trade Name: EPREX*1SIR 40000UI/ML 1ML
INN or Proposed INN: Erythropoietin
ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
515NCT01082653
(ClinicalTrials.gov)
March 20101/3/2010Safety/Efficacy Study for the Treatment of Amyotrophic Lateral SclerosisPhase I, Single Center, Prospective, Non-randomized, Open Label, Safety/Efficacy Study of the Infusion of Autologous Bone Marrow-derived Stem Cells, in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: autologous bone marrow-derived stem cellsTCA Cellular TherapyNULLSuspended18 Years80 YearsBoth6Phase 1United States
516NCT01089010
(ClinicalTrials.gov)
March 201016/3/2010A Study of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II, Double-Blind, Randomized, Placebo-Controlled, Three-Way Crossover, Pharmacokinetic and Pharmacodynamic Study of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Placebo;Drug: 250 mg CK-2017357;Drug: 500 mg CK-2017357CytokineticsNULLCompleted18 YearsN/AAll67Phase 2United States
517NCT01041222
(ClinicalTrials.gov)
January 201030/12/2009Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene MutationsA Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of ISIS 333611 Administered Intrathecally to Patients With Familial Amyotrophic Lateral Sclerosis Due to Superoxide Dismutase 1 Gene MutationsFamilial Amyotrophic Lateral SclerosisDrug: ISIS 333611Isis PharmaceuticalsMuscular Dystrophy Association;ALS AssociationCompleted18 YearsN/ABoth33Phase 1United States
518NCT01083667
(ClinicalTrials.gov)
November 200917/12/2009SOD1 Inhibition by Pyrimethamine in Familial Amyotrophic Lateral Sclerosis (ALS)Phase I/II Study of SOD1 Inhibition by Pyrimethamine in Familial ALSFamilial Amyotrophic Lateral SclerosisDrug: PyrimethamineWeill Medical College of Cornell UniversityMuscular Dystrophy AssociationCompleted18 YearsN/AAll32Phase 1/Phase 2United States;Germany;Italy;Sweden
519NCT01016522
(ClinicalTrials.gov)
November 200918/11/2009Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)Safety and Tolerability of the Ketogenic Diet in ALSAmyotrophic Lateral SclerosisDietary Supplement: KetoCalJohns Hopkins UniversityNutricia North America;Cornell UniversityTerminated18 YearsN/ABoth1Phase 3United States
520NCT00983983
(ClinicalTrials.gov)
October 200923/9/2009High Fat/High Calorie Trial in Amyotrophic Lateral SclerosisPhase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDietary Supplement: Oxepa;Dietary Supplement: Jevity 1.5;Dietary Supplement: Jevity 1.0Massachusetts General HospitalMuscular Dystrophy AssociationCompleted18 YearsN/AAll28Phase 2United States
521NCT00982150
(ClinicalTrials.gov)
September 200922/9/2009Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: TalampanelTeva Pharmaceutical IndustriesNULLTerminated18 Years80 YearsBoth446Phase 2United States;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain
522EUCTR2008-007320-25-ES
(EUCTR)
10/08/200916/07/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol.Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. ESCLEROSIS LATERAL AMIOTRÓFICA.ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles due to destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: TRO19622
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2France;Belgium;Spain;Germany;United Kingdom
523JPRN-UMIN000002276
2009/08/0101/08/2009Developmental research of communication devices based on the brain machine interface using electroencephalogramsDevelopmental research of communication devices based on the brain machine interface using electroencephalograms - Communication devices using EEG-based BMI amyotrophic lateral sclerosisLet the patients use the communication devices to select characters on a computer monitor as they intend by recording EEG.Osaka UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Not applicableJapan
524EUCTR2008-007320-25-GB
(EUCTR)
24/07/200914/04/2009 Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. Disease under investigation : Amyotrophic lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral Sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOSNULLNot Recruiting Female: yes
Male: yes
470 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Belgium;Germany;United Kingdom
525NCT00931944
(ClinicalTrials.gov)
July 200930/6/2009Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)An Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: KNS-760704Knopp BiosciencesNULLCompleted21 Years80 YearsAll74Phase 2United States
526NCT00965497
(ClinicalTrials.gov)
July 20097/8/2009Escitalopram (Lexapro) for Depression MS or ALSAn Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple SclerosisMajor Depression;Multiple Sclerosis;Amyotrophic Lateral SclerosisDrug: escitalopramUniversity of South CarolinaNULLCompleted18 Years70 YearsAll13Phase 3United States
527EUCTR2008-007320-25-DE
(EUCTR)
24/06/200918/02/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2/3United Kingdom;Germany;Belgium;France;Spain
528EUCTR2008-006722-34-IT
(EUCTR)
23/06/200911/12/2008Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS LithiumMulticentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium Amyotrophic Lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: CARBOLITHIUM
INN or Proposed INN: Lithium
ISTITUTO SUPERIORE DI SANITA`NULLNot RecruitingFemale: yes
Male: yes
Italy
529EUCTR2008-006224-61-ES
(EUCTR)
12/06/200904/05/2009Ensayo clínico multicéntrico, aleatorizado, controlado para evaluar la eficacia del tratamiento con carbonato de litio en pacientes con Esclerosis Lateral AmiotróficaEnsayo clínico multicéntrico, aleatorizado, controlado para evaluar la eficacia del tratamiento con carbonato de litio en pacientes con Esclerosis Lateral Amiotrófica Esclerosis Lateral Amiotrófica
MedDRA version: 9;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: PLENUR
INN or Proposed INN: LITIO CARBONATO
Other descriptive name: LITHIUM CARBONATE
Institut de Recerca de l'Hospital de la Santa Creu i Sant PauNULLNot RecruitingFemale: yes
Male: yes
Spain
530EUCTR2008-007320-25-BE
(EUCTR)
08/06/200928/04/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3France;Spain;Belgium;Germany;United Kingdom
531NCT00925847
(ClinicalTrials.gov)
June 200919/6/2009Effect of Lithium Carbonate in Patients With Amyotrophic Lateral SclerosisOpen Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLAAmyotrophic Lateral SclerosisDrug: lithiumAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/ABoth23Phase 2France
532NCT01384162
(ClinicalTrials.gov)
June 200923/6/2011An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral SclerosisAn Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis, Using an Implanted Catheter and SynchroMed® II PumpAmyotrophic Lateral SclerosisDrug: sNN0029Newron Sweden ABMedtronic;ICON Clinical ResearchTerminated18 Years75 YearsBoth15Phase 1/Phase 2Belgium
533EUCTR2008-005106-38-ES
(EUCTR)
14/05/200926/02/2009ENSAYO CLÍNICO RANDOMIZADO DOBLE CIEGO DE CARBONATO DE LITIO COMO TERAPIA DE ASOCIACIÓN EN ESCLEROSIS LATERAL AMIOTRÓFICA (FASE II) - LIELAENSAYO CLÍNICO RANDOMIZADO DOBLE CIEGO DE CARBONATO DE LITIO COMO TERAPIA DE ASOCIACIÓN EN ESCLEROSIS LATERAL AMIOTRÓFICA (FASE II) - LIELA Esclerosis Lateral Amiotrofica
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: PLENUR
INN or Proposed INN: LITIO CARBONATO
Other descriptive name: LITHIUM CARBONATE
Lucia Galan Hospital Clinico San CarlosNULLNot RecruitingFemale: yes
Male: yes
280Spain
534NCT00875446
(ClinicalTrials.gov)
May 13, 20092/4/2009First Time in Human Study of GSK1223249 in Amyotrophic Lateral SclerosisA Single and Repeat Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of GSK1223249 in ALS PatientsAmyotrophic Lateral SclerosisDrug: PLACEBO;Drug: GSK1223249GlaxoSmithKlineNULLCompleted18 Years80 YearsAll76Phase 1United States;France;Italy;United Kingdom
535NCT00868166
(ClinicalTrials.gov)
April 30, 200923/3/2009Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALSPhase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With RiluzoleAmyotrophic Lateral SclerosisDrug: Olesoxime;Drug: Placebo Comparator;Drug: RiluzoleHoffmann-La RocheEuropean CommissionCompleted18 Years80 YearsAll512Phase 3Belgium;France;Germany;Spain;United Kingdom;Netherlands
536NCT00886977
(ClinicalTrials.gov)
April 200921/4/2009Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: YAM80Yoshino Neurology ClinicNULLActive, not recruiting25 Years65 YearsBoth25Phase 2Japan
537EUCTR2009-010060-41-IT
(EUCTR)
24/02/200906/03/2009Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - NDEvaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND Amyotrophic Lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: LITIO CARBONATO
INN or Proposed INN: Lithium
Trade Name: RILUTEK
INN or Proposed INN: Riluzole
AZIENDA OSPEDALIERA PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
538EUCTR2008-006891-31-GB
(EUCTR)
17/02/200928/07/2010A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALSA randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Lithium Apogepha
Product Name: Lithium Carbonate
Other descriptive name: LITHIUM CARBONATE
Trade Name: Lithium Carbonate
Product Name: Lithium Carbonate
Other descriptive name: LITHIUM CARBONATE
Trade Name: Lithium Citrate
Product Name: Lithium Citrate
Other descriptive name: LITHIUM CITRATE
King's College LondonNULLNot RecruitingFemale: yes
Male: yes
220Phase 4United Kingdom
539EUCTR2008-007320-25-FR
(EUCTR)
17/02/200916/03/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3France;Spain;Belgium;Germany;United Kingdom
540JPRN-UMIN000008527
2009/01/0125/07/2012Study of efficacy and safety of NDDPX08 in ALS patientsStudy of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research Amyotrophic Lateral SclerosisFor patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level.
The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment.
Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study.
FeGALSNULLComplete: follow-up complete20years-old75years-oldMale and Female50Not selectedJapan
541NCT00818389
(ClinicalTrials.gov)
January 20096/1/2009Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in Combination With Riluzole in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Lithium Carbonate;Drug: Riluzole;Drug: placeboMassachusetts General HospitalALS Association;ALS Society of Canada;National Institute of Neurological Disorders and Stroke (NINDS);University of Toronto;State University of New York - Upstate Medical University;Columbia University;University of KentuckyTerminated18 YearsN/AAll84Phase 2/Phase 3United States;Canada
542NCT00706147
(ClinicalTrials.gov)
January 200924/6/2008Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral SclerosisPhase II/III Randomized, Placebo-Controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Arimoclomol;Drug: PlaceboUniversity of MiamiMassachusetts General HospitalCompleted18 YearsN/AAll38Phase 2/Phase 3United States
543NCT02242071
(ClinicalTrials.gov)
December 200812/9/2014Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral SclerosisThe Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Stem CellNeurogen Brain and Spine InstituteNULLWithdrawn18 Years80 YearsAll0Phase 1India
544NCT01984814
(ClinicalTrials.gov)
December 20088/11/2013Stem Cell Therapy for Amyotrophic Lateral SclerosisThe Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on the Survival Duration in Amyotrophic Lateral Sclerosis - A Retrospective Control StudyAmyotrophic Lateral SclerosisBiological: Stem cellNeurogen Brain and Spine InstituteNULLWithdrawn26 Years76 YearsAll0Phase 2India
545NCT00800501
(ClinicalTrials.gov)
December 200829/11/2008A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral SclerosisA Double-blind, Randomised, Parallel Group Safety and Tolerability Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis, Using an Implanted Catheter and SynchroMed® II PumpAmyotrophic Lateral SclerosisDrug: sNN0029;Drug: PlaceboNewron Sweden ABMedtronic;ICON Clinical ResearchCompleted18 Years75 YearsBoth18Phase 1/Phase 2Belgium
546EUCTR2007-003775-39-DE
(EUCTR)
29/10/200809/09/2008Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite lossRandomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite loss patients with amyotrophic lateral sclerosisTrade Name: Zyprexa
INN or Proposed INN: OLANZAPINE
Charité – Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes
Germany
547EUCTR2008-002062-62-NL
(EUCTR)
14/10/200802/06/2008A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
548EUCTR2008-003707-32-FR
(EUCTR)
09/10/200822/08/2008Etude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLAEtude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLA Patient atteint de sclérose latérale amyotrophique.
MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Téralithe LP
Product Name: Téralithe LP
INN or Proposed INN: Carbonate de lithium
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
549EUCTR2008-002062-62-FR
(EUCTR)
22/09/200819/06/2008A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
540Phase 2France;Hungary;Belgium;Spain;Germany;Netherlands;Italy
550EUCTR2008-002062-62-HU
(EUCTR)
17/09/200817/12/2008A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS).A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
551EUCTR2008-002110-22-NL
(EUCTR)
16/09/200805/08/2008A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALSA randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS Amyotrophic lateral sclerosis (ALS) is a disease characterised by progressive degeneration of motor neurons in brain and spinal cord leading to muscle weakness. ALS can occur at anytime in adulthood. Muscle weakness gradually progresses. Approximately 50% of patients die within 3 years after onset of symptoms, usually as the result of respiratory failure. To date, only one drug, i.e. riluzole, has proven to extend survival in patients with ALS, but only by approximately 3 to 6 months.
MedDRA version: 9.1;Level: LLT;Classification code 10052889;Term: ALS
Trade Name: Lithiumcarbonaat 400 PCH tabletten
Product Name: Lithiumcarbonaat
Other descriptive name: LITHIUM CARBONATE
Prof. dr L.H. van den Berg, UMC-UtrechtNULLNot RecruitingFemale: yes
Male: yes
Netherlands
552EUCTR2008-002062-62-DE
(EUCTR)
08/09/200819/01/2009A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). - ALSTARA Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). - ALSTAR Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
553NCT00696332
(ClinicalTrials.gov)
September 200810/6/2008Talampanel for Amyotrophic Lateral Sclerosis (ALS)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)ALSDrug: Talampanel;Other: placeboTeva Pharmaceutical IndustriesNULLCompleted18 Years80 YearsBoth559Phase 2United States;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain
554NCT00748501
(ClinicalTrials.gov)
September 20084/9/2008Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Phase 2 Repeat-Dosing Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: SB-509Sangamo BiosciencesNULLCompleted18 Years85 YearsBoth45Phase 2United States
555EUCTR2008-002062-62-ES
(EUCTR)
13/08/200826/06/2008Estudio multinacional, multicéntrico, randomizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, tolerabilidad y seguridad de Talampanel en pacientes con Esclerosis Lateral Amiotrófica (ELA)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)Estudio multinacional, multicéntrico, randomizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, tolerabilidad y seguridad de Talampanel en pacientes con Esclerosis Lateral Amiotrófica (ELA)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) Esclerosis Lateral Amiotrófica (ELA).Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
540Phase 2France;Hungary;Belgium;Spain;Germany;Netherlands;Italy
556EUCTR2008-002062-62-BE
(EUCTR)
31/07/200811/07/2008A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS).A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Product Name: talampanel
Product Code: TV-7110
INN or Proposed INN: Not available yet
Other descriptive name: talampanel
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
557EUCTR2008-002062-62-IT
(EUCTR)
16/06/200827/06/2008A Multinational, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) - ALSTARA Multinational, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) - ALSTAR Amyotrophic Lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier
Product Name: tallampanel
Product Code: TV-7110
Product Name: talampanel
Teva Pharmaceutical Industries,LtdNULLNot RecruitingFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
558NCT00919555
(ClinicalTrials.gov)
June 20088/6/2009Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)Phase IIA Trial: Tretinoin and Pioglitazone HCL Combination Therapy in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Pioglitazone and Tretinoin;Drug: Tretinoin and Pioglitazone HCL;Drug: PlaceboPhoenix Neurological Associates, LTDNULLCompleted18 Years85 YearsBoth28Phase 1/Phase 2United States
559NCT00694941
(ClinicalTrials.gov)
June 20086/6/2008A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: ONO-2506POOno Pharmaceutical Co. LtdNULLCompleted18 YearsN/ABoth15Phase 2Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
560NCT00877604
(ClinicalTrials.gov)
June 20087/4/2009Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral SclerosisA Randomized, Double-blind Multicenter Pilot Study vs. Placebo for the Evaluation of Efficacy and Tolerability of Tauroursodeoxycholic Acid Administered by Oral Route as Add on Treatment in Patients Affected by Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: tauroursodeoxycholic acid (TUDCA);Drug: PlaceboFondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity of Palermo;Federico II UniversityCompleted18 Years75 YearsAll34Phase 2Italy
561EUCTR2007-004723-37-DE
(EUCTR)
16/05/200829/01/2008A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
273Phase 2United Kingdom;Germany;Belgium;France
562EUCTR2007-004723-37-GB
(EUCTR)
12/05/200815/02/2008A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
273Phase 2Germany;United Kingdom;Belgium;France
563NCT00690118
(ClinicalTrials.gov)
May 20082/6/2008Study of Pioglitazone in Patients With Amyotrophic Lateral SclerosisEfficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)Amyotrophic Lateral SclerosisDrug: pioglitazone;Drug: placeboUniversity of UlmNULLTerminated18 YearsN/ABoth219Phase 2Germany;Italy
564NCT00790582
(ClinicalTrials.gov)
May 200812/11/2008A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: lithium carbonateForbes Norris MDA/ALS Research CenterMuscular Dystrophy AssociationCompleted21 Years80 YearsAll109Phase 2United States
565EUCTR2007-004723-37-BE
(EUCTR)
23/04/200831/01/2008A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
273Phase 2United Kingdom;Germany;Belgium;France
566EUCTR2006-005410-13-DE
(EUCTR)
22/04/200821/01/2008EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE).EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE). Male or female adult patients with amyotrophic lateral sclerosis (ALS) accoring to the El Escorial Criteria for the diognosis of ALS and treated for at least 3 month with 100 mg riluzole (standard therapy).
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Actos 15 mg
INN or Proposed INN: Pioglitazone
Trade Name: Actos 30 mg
INN or Proposed INN: Pioglitazone
Trade Name: Actos 45 mg
INN or Proposed INN: Pioglitazone
University Hospital of UlmNULLNot RecruitingFemale: yes
Male: yes
Germany
567EUCTR2007-004723-37-FR
(EUCTR)
15/04/200806/02/2008A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
273Phase 2France;Belgium;Germany;United Kingdom
568EUCTR2008-001094-15-IT
(EUCTR)
10/03/200810/03/2008SINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OFAMYOTROPHIC LATERAL SCLEROSIS (ALS) - NDSINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OFAMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND ALS patient according with the El-Escorial criteria
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: CARBOLITHIUM*100CPS 150MG
INN or Proposed INN: Lithium
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
569NCT00647296
(ClinicalTrials.gov)
March 200826/3/2008Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)A 2-Part, Randomized, Double-Blind, Safety and Tolerability Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: KNS-760704;Drug: PlaceboKnopp BiosciencesNULLCompleted21 Years80 YearsAll102Phase 2United States
570EUCTR2007-001592-10-IT
(EUCTR)
15/02/200815/01/2008A randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholicacid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALSA randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholicacid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALS AMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: Tauroursodeoxycholic acid
INN or Proposed INN: Tauroursodeoxycholic acid
ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
571NCT00445172
(ClinicalTrials.gov)
February 20086/3/2007A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: E0302 (mecobalamin)Eisai Co., Ltd.NULLCompleted20 YearsN/AAll135Phase 2/Phase 3Japan
572EUCTR2007-002117-39-ES
(EUCTR)
31/01/200812/02/2008MEMANTINA (Ebixa X) PARA LA DISCAPACIDAD FUNCIONAL EN LA ESCLEROSIS LATERAL AMIOTRÓFICAMEMANTINE (Ebixa R) FOR FUNCTIONAL DISABILITY IN AMYOTROPHIC LATERAL SCLEROSIS . - MEDALSMEMANTINA (Ebixa X) PARA LA DISCAPACIDAD FUNCIONAL EN LA ESCLEROSIS LATERAL AMIOTRÓFICAMEMANTINE (Ebixa R) FOR FUNCTIONAL DISABILITY IN AMYOTROPHIC LATERAL SCLEROSIS . - MEDALS Esclerosis Lateral AmiotroficaAmyotrophic lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: EBIXA
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Jorge Matias-Guiu GuiaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Spain
573NCT00753571
(ClinicalTrials.gov)
January 200815/9/2008Cistanche Total Glycosides for Amyotrophic Lateral Sclerosis: A Randomized Control Trial (RCT) Study Assessing Clinical ResponseCistanche Total Glycosides Treatment for Amyotrophic Lateral Sclerosis: A Randomized Control Trial Study Assessing Clinical ResponseAmyotrophic Lateral SclerosisDrug: Cistanche Total GlycosidesPeking UniversityNULLRecruiting18 Years65 YearsBoth40Phase 2China
574NCT00561366
(ClinicalTrials.gov)
January 200816/11/2007A Multicenter, Double-Blind Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With ALSA Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Placebo;Drug: ArimoclomolCytRxNULLWithdrawn18 YearsN/ABoth0Phase 2United States;Canada
575NCT00573443
(ClinicalTrials.gov)
December 200713/12/2007Safety and Efficacy of AVP-923 in PBA Patients With ALS or MSA Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)Pseudobulbar Affect (PBA)Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: PlaceboAvanir PharmaceuticalsINC ResearchCompleted18 Years80 YearsAll326Phase 3United States;Argentina;Brazil
576EUCTR2007-004165-17-IT
(EUCTR)
25/09/200715/10/2007Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - NDEfficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND Amyotrophic lateral sclerosis (ALS)
MedDRA version: 6.1;Level: PT;Classification code 10002026
INN or Proposed INN: CeftriaxoneAZIENDA OSPEDALIERA PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
577NCT00600873
(ClinicalTrials.gov)
August 20075/1/2008R(+)PPX High Dose Treatment of ALSPharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six MonthsAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.NULLCompleted30 Years80 YearsBoth10Phase 1/Phase 2United States
578EUCTR2007-002379-16-IT
(EUCTR)
29/05/200709/11/2007MULTICENTER TRIAL (SINGLE BLIND)VS ON THE EFFICACY OF LITHIUM SALTS +RILUZOLE VS PLACEBO+RILUZOLE IN PATIENTS AFFECTED BY AMYOTROPHIC LATERAL SCLEROSIS - EFFICACY OF LITHIUM IN ALSMULTICENTER TRIAL (SINGLE BLIND)VS ON THE EFFICACY OF LITHIUM SALTS +RILUZOLE VS PLACEBO+RILUZOLE IN PATIENTS AFFECTED BY AMYOTROPHIC LATERAL SCLEROSIS - EFFICACY OF LITHIUM IN ALS Patients affected by amyotrophic lateral sclerosis (ALS)
MedDRA version: 6.1;Level: PT;Classification code 10002026
Trade Name: CARBOLITHIUM
INN or Proposed INN: Lithium
I.N.M. NEUROMED (I.R.C.C.S.) S.R.L. GIA' SANATRIXNULLNot RecruitingFemale: yes
Male: yes
Italy
579EUCTR2006-002660-26-NL
(EUCTR)
17/04/200703/01/2007A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
580NCT00444613
(ClinicalTrials.gov)
April 20076/3/2007A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: E0302 (mecobalamin);Drug: PlaceboEisai Co., Ltd.NULLCompleted20 YearsN/ABoth373Phase 2/Phase 3Japan
581NCT00635960
(ClinicalTrials.gov)
March 20073/3/2008Growth Hormone in Amyotrophic Lateral SclerosisEfficacy, Safety and Tolerability of Growth Hormone in Patients With Amyotrophic Lateral Sclerosis as add-on Therapy to RiluzoleAmyotrophic Lateral SclerosisDrug: Growth Hormone (Somatropin);Drug: PlaceboFederico II UniversityIstituto Biostrutture e Immagini, CNR Naples;Agenzia Italiana del FarmacoCompleted40 Years85 YearsBoth40Phase 2Italy
582NCT00409721
(ClinicalTrials.gov)
March 20078/12/2006The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALSAmyotrophic Lateral SclerosisDrug: MemantineUniversity of AlbertaALS AssociationCompleted18 Years80 YearsBoth42Phase 2Canada
583EUCTR2006-002660-26-IT
(EUCTR)
01/02/200710/11/2006A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - NDA MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506ONO PHARMA UK LTDNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
584EUCTR2006-002660-26-GB
(EUCTR)
08/01/200720/09/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
585NCT00424463
(ClinicalTrials.gov)
January 200717/1/2007Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)Amyotrophic Lateral Sclerosis (ALS)Drug: MCI-186;Drug: Placebo of MCI-186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 YearsN/AAll181Phase 3Japan
586EUCTR2006-002660-26-DE
(EUCTR)
20/12/200619/01/2007A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria
587EUCTR2006-002660-26-FR
(EUCTR)
12/12/200610/10/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Phase 2France;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
588NCT00397423
(ClinicalTrials.gov)
December 20068/11/2006G-CSF Treatment for Amyotrophic Lateral Sclerosis: A RCT Study Assessing Clinical ResponseGranulocyte-Colony Stimulating Factor Treatment for Amyotrophic Lateral Sclerosis: A Randomized Control Trial Study Assessing Clinical ResponseAmyotrophic Lateral SclerosisDrug: Granulocyte Colony Stimulating Factor;Drug: NSPeking UniversityNULLCompleted18 Years65 YearsBoth40Phase 2China
589NCT00372879
(ClinicalTrials.gov)
December 20065/9/2006Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALSRandomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis.Amyotrophic Lateral SclerosisDietary Supplement: Vitamin ELawson Health Research InstituteNULLCompleted18 YearsN/ABoth32Phase 3Canada
590NCT00415519
(ClinicalTrials.gov)
December 200622/12/2006Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification IIIAn Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled MannerAmyotrophic Lateral Sclerosis (ALS)Drug: MCI-186;Drug: Placebo of MCI-186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years75 YearsBoth25Phase 3Japan
591EUCTR2006-002660-26-BE
(EUCTR)
13/11/200628/09/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
592EUCTR2006-002660-26-AT
(EUCTR)
13/11/200606/11/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
593NCT00403104
(ClinicalTrials.gov)
November 200622/11/2006Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of RandomizationAmyotrophic Lateral Sclerosis (ALS)Drug: ONO-2506POOno Pharmaceutical Co. LtdNULLCompleted18 Years74 YearsBoth420Phase 2Austria;Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
594EUCTR2006-001688-49-GB
(EUCTR)
14/08/200628/04/2006A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. Early stage of amyotrophic lateral sclerosis (ALS)
MedDRA version: 8.1;Level: PT;Classification code 10002026
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
TEVA Pharmaceutical Industries. Ltd.NULLNot Recruiting Female: yes
Male: yes
366 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Germany;Italy;United Kingdom
595EUCTR2006-001688-49-DE
(EUCTR)
31/07/200624/05/2006A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. Early stage of amyotrophic lateral sclerosis (ALS)
MedDRA version: 8.1;Level: PT;Classification code 10002026
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
TEVA Pharmaceutical Industries. Ltd.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Germany;Belgium;Italy
596NCT00355576
(ClinicalTrials.gov)
July 200621/7/2006Combination Therapy Selection Trial in Amyotrophic Lateral SclerosisPhase II Combination Therapy Selection Trial in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Celecoxib;Drug: Creatine;Drug: MinocyclineColumbia UniversityALS Association;PfizerCompleted21 Years85 YearsBoth86Phase 2United States
597NCT00349622
(ClinicalTrials.gov)
July 20065/7/2006Clinical Trial Ceftriaxone in Subjects With ALSClinical Trial Ceftriaxone in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;ALSDrug: ceftriaxone;Other: placeboMassachusetts General HospitalNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 YearsN/AAll513Phase 3United States;Canada;Puerto Rico
598EUCTR2006-001688-49-BE
(EUCTR)
26/06/200610/05/2006A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. Early stage of amyotrophic lateral sclerosis (ALS)
MedDRA version: 8.1;Level: PT;Classification code 10002026
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
TEVA Pharmaceutical Industries. Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Belgium;Italy
599NCT00324454
(ClinicalTrials.gov)
May 20069/5/2006Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron DiseaseA Pilot Trial of Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron DiseaseMotor Neuron Disease;Amyotrophic Lateral Sclerosis;Primary Lateral Sclerosis;Progressive Muscular AtrophyBiological: LevetiracetamDuke UniversityUCB PharmaCompleted18 YearsN/ABoth20Phase 2United States
600NCT00330681
(ClinicalTrials.gov)
May 200626/5/2006Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.Amyotrophic Lateral Sclerosis (ALS)Drug: MCI-186;Drug: Placebo of MCI-186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years75 YearsAll206Phase 3Japan
601EUCTR2005-005152-40-IT
(EUCTR)
19/04/200607/04/2006MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALSMULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS ALS
MedDRA version: 6.1;Level: PT;Classification code 10002026
Product Name: ALPHA-LIPOIC ACID
INN or Proposed INN: Tioctic acid
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Italy
602NCT00298597
(ClinicalTrials.gov)
March 20061/3/2006Influence of G-CSF and EPO on Associative Learning and Motor SkillsInfluence of G-CSF and EPO on Associative Learning and Motor SkillsChronic Stroke;Amyotrophic Lateral SclerosisDrug: granulocyte - colony stimulating factor (G-CSF);Drug: erythropoetin (EPO)University Hospital MuensterNULLCompleted18 YearsN/ABoth180Phase 2Germany
603NCT00231140
(ClinicalTrials.gov)
December 200530/9/2005Pilot-Study of Thalidomide in Amyotrophic Lateral Sclerosis (ALS)Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Thalidomide (drug)Charite University, Berlin, GermanyNULLTerminated25 Years80 YearsBoth40Phase 2Germany
604NCT00596115
(ClinicalTrials.gov)
October 20055/1/2008Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/DayOpen Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per DayAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.University of Pittsburgh;University of NebraskaTemporarily not available30 Years80 YearsBothN/ANULL
605NCT00244244
(ClinicalTrials.gov)
October 200525/10/2005A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALSA Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: arimoclomolCytRxNULLCompleted18 YearsN/ABoth80Phase 2United States
606EUCTR2005-003248-75-IT
(EUCTR)
31/08/200502/09/2005PILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSISPILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS SLOWING OF ALS PROGRESSION
MedDRA version: 6.1;Level: PT;Classification code 10002026
Trade Name: MYELOSTIM 34*1FL 263MCG+1SIR
INN or Proposed INN: Lenograstim
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
607EUCTR2005-005873-31-IT
(EUCTR)
01/08/200514/03/2006A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - NDA randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - ND Amiotrophic Lateral Sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10002026
Trade Name: EPREX IV SC 1FL 1ML 40000 UI
INN or Proposed INN: Erythropoietin
ISTITUTO NEUROLOGICO CARLO BESTANULLNot RecruitingFemale: yes
Male: yes
20Italy
608NCT00140218
(ClinicalTrials.gov)
August 200530/8/2005R(+) Pramipexole in Early Amyotrophic Lateral SclerosisFutility Study of R(+) Pramipexole in Early Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.University of PittsburghCompleted21 Years85 YearsBoth30Phase 1/Phase 2United States
609NCT00353665
(ClinicalTrials.gov)
July 200518/7/2006Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)Phase 2-3 - Memantine for Disability in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Memantine (Ebixa);Drug: riluzole;Drug: PlaceboUniversity of LisbonH. Lundbeck A/SCompleted20 Years75 YearsBoth63Phase 2/Phase 3Portugal
610NCT01020331
(ClinicalTrials.gov)
June 200520/11/2009Memantine Therapy in Amyotrophic Lateral SclerosisPhase IIA Open Label Trial of Memantine in Combination With Riluzole (Customary Care) for the Treatment of ALSAmyotrophic Lateral SclerosisDrug: MemantinePhoenix Neurological Associates, LTDForest LaboratoriesCompleted18 Years85 YearsBoth20Phase 2United States
611EUCTR2004-004158-23-IT
(EUCTR)
15/04/200509/08/2007DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - NDDOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND Amyotrophic lateral sclerosis therapy
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: ZIBREN*20BUST 500MG
INN or Proposed INN: Acetylcarnitine
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot RecruitingFemale: yes
Male: yes
Italy
612NCT00136110
(ClinicalTrials.gov)
April 200524/8/2005Trial of Sodium Valproate in Amyotrophic Lateral SclerosisA Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALSAmyotrophic Lateral SclerosisDrug: Sodium ValproateUMC UtrechtPrincess Beatrix Fund, The NetherlandsCompleted18 Years85 YearsBoth165Phase 3Netherlands
613NCT00812851
(ClinicalTrials.gov)
April 200521/11/2008Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Cramps;Amyotrophic Lateral SclerosisDrug: DronabinolCantonal Hospital of St. GallenALS AssociationCompleted18 YearsN/ABoth24N/ASwitzerland
614NCT00243932
(ClinicalTrials.gov)
April 200524/10/2005Clinical Trial of High Dose CoQ10 in ALSClinical Trial of High Dose CoQ10 in ALSAmyotrophic Lateral Sclerosis;Lou Gehrig's DiseaseDrug: coenzyme Q10;Drug: PlaceboColumbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed21 Years85 YearsAll185Phase 2United States
615NCT00107770
(ClinicalTrials.gov)
April 20057/4/2005Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: sodium phenylbutyrateDepartment of Veterans AffairsMuscular Dystrophy AssociationCompleted18 YearsN/ABoth40Phase 1/Phase 2United States
616NCT00140452
(ClinicalTrials.gov)
February 200531/8/2005Phase II Study Using Thalidomide for the Treatment of ALSPhase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;ALSDrug: ThalidomideDartmouth-Hitchcock Medical CenterCelgene CorporationCompleted18 Years80 YearsBoth24Phase 2United States
617EUCTR2004-002855-15-DE
(EUCTR)
29/12/200402/12/2004A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis.A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. Amyotrophic Lateral SclerosisProduct Code: TCH346
INN or Proposed INN: not established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
480United Kingdom;Germany;Italy
618EUCTR2004-002855-15-GB
(EUCTR)
21/12/200404/05/2005A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis.A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. Amyotrophic Lateral SclerosisProduct Code: TCH346
INN or Proposed INN: not established
INN or Proposed INN: not established
INN or Proposed INN: not established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
480Germany;Italy;United Kingdom
619EUCTR2004-002390-23-DE
(EUCTR)
24/11/200430/11/2004Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjectsEvaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects amyotrophic lateral sclerosis
Classification code 10002026
Trade Name: RILUTEK
Product Name: RILUTEK 50 mg, film-coated tablets
INN or Proposed INN: riluzole
Aventis Pharma Ltd.NULLNot RecruitingFemale:
Male: yes
Germany
620EUCTR2004-002855-15-IT
(EUCTR)
09/11/200408/01/2007A long term extension to a randomised, double-blind, placebo-controlled, stratified, paralle-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 1.0, 2.5, 7.5 and 15 mg administered once daily in patients with Amyotrophic Lateral SclerosisA long term extension to a randomised, double-blind, placebo-controlled, stratified, paralle-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 1.0, 2.5, 7.5 and 15 mg administered once daily in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TCH346
Product Code: TCH346
Product Code: TCH346
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
476United Kingdom;Germany;Italy
621NCT00230074
(ClinicalTrials.gov)
November 200428/9/2005A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)Amyotrophic Lateral SclerosisDrug: TCH346NovartisNULLCompleted21 Years80 YearsBoth350Phase 2United States
622EUCTR2004-002912-27-ES
(EUCTR)
04/10/200427/04/2005Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD).Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD). Amyotrophic lateral sclerosis
MedDRA version: 7.0;Level: LL 1;Classification code 10002026
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: (R)-(-)-2-Propyloctaroic acid
ONO PHARMA UK LTDNULLNot RecruitingFemale: yes
Male: yes
500Phase 2Spain
623NCT00072709
(ClinicalTrials.gov)
September 20037/11/2003Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: TCH346Novartis PharmaceuticalsNULLCompleted21 Years80 YearsBoth551Phase 2United States;Belgium;Canada;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
624NCT00125203
(ClinicalTrials.gov)
July 200327/7/2005Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;SialorrheaDrug: Botulinum toxin type B (Myobloc);Procedure: Injection of salivary glandsThe University of Texas Health Science Center at San AntonioALS Association;University of Kansas;Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical SystemCompleted21 Years85 YearsBoth20Phase 2/Phase 3United States
625NCT00035815
(ClinicalTrials.gov)
June 20036/5/2002Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) TrialInsulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Insulin like growth factor, type 1;Drug: PlaceboMayo ClinicNational Institute of Neurological Disorders and Stroke (NINDS);ALS Association;CephalonCompleted18 Years80 YearsAll330Phase 3United States;Puerto Rico
626NCT00069186
(ClinicalTrials.gov)
June 200317/9/2003Study of Creatine Monohydrate in Patients With Amyotrophic Lateral SclerosisA Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: Creatine MonohydrateThe Avicena GroupNULLActive, not recruiting21 Years80 YearsBoth107Phase 3United States
627NCT00047723
(ClinicalTrials.gov)
January 200316/10/2002Minocycline to Treat Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: minocyclineNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted21 Years85 YearsBoth400Phase 3United States
628NCT00070993
(ClinicalTrials.gov)
December 20029/10/2003Creatine for the Treatment of Amyotrophic Lateral SclerosisClinical Trial of Creatine in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: creatine monohydrateNational Center for Complementary and Integrative Health (NCCIH)Office of Dietary Supplements (ODS)Completed21 Years80 YearsBoth110Phase 2United States
629NCT00036413
(ClinicalTrials.gov)
January 20029/5/2002A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral SclerosisA 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.Amyotrophic Lateral SclerosisDrug: TCH346Novartis PharmaceuticalsNULLCompleted40 Years75 YearsBoth44Phase 2United States
630NCT00542412
(ClinicalTrials.gov)
January 200110/10/2007CARE Canadian ALS Riluzole EvaluationCare (Canadian ALS Riluzole Evaluation) Multicentre Phase IV Comparative Study of the Effects of Riluzole 50mg Bid on the Survival of ALS Subjects Compared to Historical ControlsAmyotrophic Lateral SclerosisDrug: RiluzoleSanofiNULLCompleted18 Years75 YearsBoth414Phase 4Canada
631NCT00214110
(ClinicalTrials.gov)
January 200113/9/2005Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS]Amyotrophic Lateral Sclerosis (ALS)Drug: TamoxifenUniversity of Wisconsin, MadisonNULLCompleted18 Years90 YearsBoth100Phase 2United States
632NCT00021697
(ClinicalTrials.gov)
January 20011/8/2001Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALSA Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: AVP-923Avanir PharmaceuticalsNULLCompleted18 Years80 YearsBoth100Phase 3United States
633NCT00005766
(ClinicalTrials.gov)
May 20001/6/2000Clinical Trial of Creatine in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: CreatinineNational Center for Research Resources (NCRR)NULLCompleted18 Years80 YearsBothPhase 2United States
634NCT00005674
(ClinicalTrials.gov)
May 200026/5/2000Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS]Amyotrophic Lateral SclerosisDrug: CreatineNational Center for Research Resources (NCRR)Muscular Dystrophy AssociationCompleted18 Years80 YearsBothPhase 2United States
635NCT00004771
(ClinicalTrials.gov)
October 199224/2/2000Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron DiseaseSpinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular AtrophyDrug: leuprolide;Drug: testosteroneNational Center for Research Resources (NCRR)Ohio State UniversityCompleted18 YearsN/AMale40Phase 2NULL
636EUCTR2020-005522-28-IT
(EUCTR)
09/08/2021A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS).A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients with Fused in Sarcoma Mutations (FUS-ALS) - FUSION: A Phase 1-3 study to evaluate the effects of ION363 in FUS-ALS patients Amyotrophic Lateral Sclerosis with Fused in Sarcoma mutations
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ION363
Product Code: [ION363]
Other descriptive name: all-P-ambo-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-deoxy-P-thioguanylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-Pthioadenylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-
IONIS PHARMACEUTICALS, INC.NULLNAFemale: yes
Male: yes
64Phase 1;Phase 3France;United States;Canada;Belgium;Turkey;Germany;United Kingdom;Japan;Italy;Korea, Republic of
637EUCTR2020-004040-29-FR
(EUCTR)
19/04/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLNAFemale: yes
Male: yes
555Phase 3United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
638EUCTR2019-001862-13-IE
(EUCTR)
04/08/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Masitinib 100mg
Product Code: AB1010
INN or Proposed INN: Masitinib Mesylate
Product Name: Masitinib 200mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
639EUCTR2010-024423-24-IE
(EUCTR)
06/11/2014A controlled clinical study to investigate the effectiveness and safety of the medicine called masitinib when used together with a currently available medicine Riluzole when treating the illness called Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 Study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS). - IRELAND Phase 2/3 study comparing Masitinib/Placebo in ALS Amyotrophic lateral Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Masitinib 100 mg Tablets
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: SUB126308
Product Name: Masitinib 200 mg Tablets
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: SUB126308
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Argentina;Belgium;Romania;Netherlands;Germany
640EUCTR2019-001862-13-GB
(EUCTR)
24/03/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Masitinib 100mg
Product Code: AB1010
INN or Proposed INN: Masitinib Mesylate
Other descriptive name: na
Product Name: Masitinib 200mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLNAFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
641EUCTR2020-005522-28-NL
(EUCTR)
27/05/2022A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS).A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients with Fused in Sarcoma Mutations (FUS-ALS) Amyotrophic Lateral Sclerosis with Fused in Sarcoma mutations
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ION363
Product Code: ION363
INN or Proposed INN: Not assigned
Other descriptive name: all-P-ambo-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-deoxy-P-thioguanylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-P-thioadenylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioadenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidine
Ionis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
89Phase 1;Phase 2;Phase 3France;United States;Canada;Belgium;Brazil;Korea, Democratic People's Republic of;Turkey;Germany;Netherlands;United Kingdom;Italy;Japan
642EUCTR2020-004040-29-BE
(EUCTR)
28/05/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLNAFemale: yes
Male: yes
555Phase 3United States;Portugal;Spain;Ireland;Switzerland;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden
643EUCTR2020-005522-28-BE
(EUCTR)
13/08/2021A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS).A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients with Fused in Sarcoma Mutations (FUS-ALS) Amyotrophic Lateral Sclerosis with Fused in Sarcoma mutations
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ION363
Product Code: ION363
INN or Proposed INN: Not assigned
Other descriptive name: all-P-ambo-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-deoxy-P-thioguanylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-P-thioadenylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioadenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidine
Ionis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
64Phase 1;Phase 2;Phase 3France;United States;Canada;Belgium;Korea, Democratic People's Republic of;Turkey;Germany;United Kingdom;Italy;Japan
644EUCTR2020-004040-29-DE
(EUCTR)
09/04/2021A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: reldesemtiv
Product Code: CK-2127107
INN or Proposed INN: reldesemtiv
Other descriptive name: RELDESEMTIV
Cytokinetics IncNULLNAFemale: yes
Male: yes
555Phase 3Portugal;United States;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden
645EUCTR2012-004987-23-NL
(EUCTR)
07/02/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
680Phase 2France;United States;Canada;Spain;Ireland;Germany;Netherlands;United Kingdom