2. 筋萎縮性側索硬化症 [臨床試験数:508,薬物数:530(DrugBank:146),標的遺伝子数:170,標的パスウェイ数:221

Searched query = "Amyotrophic lateral sclerosis", "ALS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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1NCT02478450December 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
2NCT02988297August 20217/12/2016Nebulized 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
3NCT04468919July 1, 20218/7/2020Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitOptimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitAmyotrophic Lateral Sclerosis;Brainstem Stroke;Muscular Dystrophies;Parkinson's Disease and Parkinsonism;Multiple System Atrophy;Brain Tumor Adult;Spinal Cord Injuries;Locked-in SyndromeBehavioral: BCI-FIT multi-modal access;Behavioral: BCI-FIT adaptive signal modeling;Behavioral: BCI-FIT active querying;Behavioral: BCI-FIT language modelingOregon Health and Science UniversityNULLNot yet recruiting18 Years75 YearsAll60N/AUnited States
4NCT03843710April 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
5NCT04505358January 30, 202123/7/2020Evaluate 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.NULLNot yet recruiting20 Years80 YearsAll30Phase 2NULL
No.TrialIDDate_
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6NCT04390386January 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
7ChiCTR20000289602021-01-012020-01-09Exploratory 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
8NCT02588807January 1, 202127/10/2015Food Supplement for the Treatment of Patients With Amyotrophic Lateral SclerosisThe Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot StudyAmyotrophic Lateral SclerosisDrug: Spirit1Herb SpiritCarmel Medical CenterSuspended18 Years75 YearsAll10Phase 1Israel
9NCT04654689January 202113/11/2020Impact of the Combined Treatment of Liposomed Polyphenols With Dutasteride on the ALS PatientsImpact of the Combined Treatment of Curcumin and Resveratrol Liposomed Polyphenols With Dutasteride 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: Dutasteride 0.5 mg;Other: Placebo microcrystalline methylcelluloseFundación Universidad Católica de Valencia San Vicente MártirNULLNot yet recruiting18 Years75 YearsAll100Phase 2Spain
10NCT04220190December 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 HealthNot yet recruiting18 YearsN/AAll18Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
11NCT04651855December 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)The National Centre for Research and DevelopmentRecruiting18 YearsN/AAll20Phase 1/Phase 2Poland
12NCT04632225December 1, 202029/10/2020Safety 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.NULLNot yet recruiting20 Years80 YearsAll18Phase 2NULL
13NCT04575727December 202029/9/2020Exploratory 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
14NCT04516096November 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.NULLEnrolling by invitation18 YearsN/AAll40Phase 2/Phase 3United States
15NCT04569435November 15, 202023/9/2020Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)A Phase 2a Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Study of Intravenous ANX005 in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: ANX005Annexon, Inc.Worldwide Clinical TrialsNot yet recruiting18 YearsN/AAll24Phase 2United States
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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16NCT04569084November 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.NULLRecruiting18 Years75 YearsAll380Phase 3United States
17NCT04391361November 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
18NCT04615923November 202029/10/2020HEALEY ALS Platform Trial - Regimen D PridopidineHEALEY ALS Platform Trial - Regimen D PridopidineAmyotrophic Lateral SclerosisDrug: Pridopidine;Drug: Matching PlaceboMerit E. Cudkowicz, MDPrilenia TherapeuticsNot yet recruiting18 YearsN/AAll160Phase 2/Phase 3NULL
19NCT04577404October 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.NULLRecruiting18 YearsN/AAll140Phase 3United States
20NCT04322149October 16, 202020/3/2020Multiple Doses of AT-1501-A201 in Adults With ALSA Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALSAmyotrophic Lateral SclerosisDrug: AT-1501Anelixis Therapeutics, Inc.NULLRecruiting18 YearsN/AAll54Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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21EUCTR2019-001862-13-SE14/10/202023/03/2020Evaluation 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Germany;Netherlands;Sweden
22NCT04562831October 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 HospitalNULLRecruiting35 YearsN/AAll380N/ANorway
23NCT03127267October 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
24ChiCTR20000359882020-10-012020-08-21Exploratory 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
25NCT03651349October 202026/8/2018To 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.NULLNot yet recruiting20 YearsN/AAll56Phase 1Taiwan
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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26NCT04579666September 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.NULLRecruiting18 YearsN/AAll228Phase 2United States
27NCT04494256September 28, 202030/7/2020A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB105 in Participants With Amyotrophic Lateral Sclerosis With or Without Poly-cytosine-adenine-guanine (CAG) Expansion in the Ataxin-2 GeneA Phase 1 Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics 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/AAll70Phase 1United States
28NCT04557410September 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 FoundationRecruitingN/AN/AAll15Phase 1United States
29EUCTR2019-001862-13-ES15/09/202012/06/2020Evaluation 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Germany;Netherlands;Sweden
30NCT04428775September 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.NULLRecruiting18 Years75 YearsAll80Phase 2United States
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
31NCT04518540September 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
32NCT04514952September 1, 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 SclerosisDrug: HB-adMSCsHope BiosciencesHope Biosciences Stem Cell Research FoundationNo longer availableN/AN/AAllUnited States
33NCT04499963August 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.NULLRecruiting18 YearsN/AAll100Phase 2United States
34EUCTR2019-004619-30-DK12/08/202003/03/2020An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
35EUCTR2019-004619-30-DE07/08/202011/02/2020An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04414345July 30, 20201/6/2020HEALEY ALS Platform Trial - Regimen C CNM-Au8HEALEY ALS Platform Trial - Regimen C CNM-Au8Amyotrophic Lateral SclerosisDrug: CNM-Au8;Drug: Matching PlaceboMerit E. Cudkowicz, MDClene NanomedicineEnrolling by invitation18 YearsN/AAll160Phase 2/Phase 3United States
37NCT04436497July 29, 20201/6/2020HEALEY ALS Platform Trial - Regimen A ZilucoplanHEALEY ALS Platform Trial - Regimen A ZilucoplanAmyotrophic Lateral SclerosisDrug: Zilucoplan;Drug: Matching PlaceboMerit E. Cudkowicz, MDRa PharmaceuticalsEnrolling by invitation18 YearsN/AAll160Phase 2/Phase 3United States
38NCT04436510July 28, 20201/6/2020HEALEY ALS Platform Trial - Regimen B VerdiperstatHEALEY ALS Platform Trial - Regimen B VerdiperstatAmyotrophic Lateral SclerosisDrug: Matching Placebo;Drug: VerdiperstatMerit E. Cudkowicz, MDBiohaven Pharmaceuticals, Inc.Enrolling by invitation18 YearsN/AAll160Phase 2/Phase 3United States
39NCT04297683July 14, 20203/3/2020HEALEY ALS Platform Trial - Master ProtocolHEALEY ALS Platform TrialAmyotrophic Lateral SclerosisDrug: Zilucoplan;Drug: Verdiperstat;Drug: CNM-Au8Merit E. Cudkowicz, MDMassachusetts General HospitalRecruiting18 YearsN/AAll480Phase 2/Phase 3United States
40NCT03766321July 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 FlorenceRecruiting18 Years70 YearsAll42N/AItaly
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2019-004619-30-SE22/06/202004/02/2020An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden
42NCT04057898May 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
43EUCTR2019-004619-30-GB26/05/202007/02/2020An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
44EUCTR2019-004619-30-FR20/05/202020/08/2020An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Italy;Switzerland;United Kingdom;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
45EUCTR2019-004619-30-ES14/05/202006/03/2020An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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Inclusion_
agemin
Inclusion_
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PhaseCountries
46EUCTR2019-002108-41-DE06/05/202017/01/2020A 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
150Phase 3United States;France;Canada;Germany;Japan;Italy
47NCT04288856April 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: BIIB078BiogenNULLEnrolling by invitation18 YearsN/AAll90Phase 1United States;Canada;Netherlands;Switzerland;United Kingdom
48EUCTR2020-000352-36-DK27/04/202013/02/2020Metabolic 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
49EUCTR2019-004619-30-NL23/04/202009/03/2020An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of
50NCT04326283April 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: Trametinib (2 mg);Drug: Riluzole (100 mg)Genuv Inc.NULLRecruiting19 Years75 YearsAll30Phase 1/Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04248465March 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 PharmaceuticalsNULLRecruiting18 YearsN/AAll354Phase 3United States;Australia;Canada;Denmark;France;Italy;Japan;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom
52EUCTR2015-004098-33-DK23/03/202002/03/2020An 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: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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 3United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Japan;Italy;Sweden;Korea, Republic of
53NCT04313166March 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 LimitedNULLRecruiting18 Years75 YearsAll70Phase 2Australia
54EUCTR2019-001862-13-SI12/03/202019/02/2020Evaluation 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
55EUCTR2019-003549-14-HU11/03/202013/01/2020A 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT04302870February 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
57NCT04245709February 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.NULLActive, not recruiting18 YearsN/AAll25Phase 2United States
58EUCTR2018-004180-31-FR31/01/202007/11/2019An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
59NCT04254913January 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
60NCT04220021January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2017-003676-31-FR31/12/201925/04/2018Inhibition 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
62NCT04066244December 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/AAll20Phase 2United States;Finland;Sweden
63NCT04098406December 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 LtdRecruiting30 Years80 YearsAll42Phase 2Australia
64EUCTR2018-004180-31-IE16/12/201902/08/2019An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
65NCT04090684December 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.NULLActive, not recruiting18 Years75 YearsAll11Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT04172792November 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, GermanyRecruiting18 YearsN/AAll64Phase 1Germany
67NCT04165850November 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.NULLActive, not recruiting18 Years75 YearsAll16Phase 2Israel
68EUCTR2018-002722-22-NL21/11/201906/06/2019 Safety 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: 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]
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
440 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noNetherlands;United Kingdom
69EUCTR2019-000826-22-FI05/11/201918/09/2019Study 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
70EUCTR2019-002302-46-ES23/10/201909/08/2019Phase 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]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 Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT04259255October 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: EdaravoneMitsubishi Tanabe Pharma America Inc.Massachusetts General HospitalRecruiting18 YearsN/AAll300United States
72NCT04309604October 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
73NCT03981536October 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
74ChiCTR20000359662019-10-102020-08-20Clinical 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
75EUCTR2019-000374-39-DE04/10/201928/05/2019Extension 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2018-004180-31-NL02/10/201923/07/2019An 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Netherlands;Germany;Sweden
77NCT04082832September 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
78EUCTR2019-000374-39-SE26/09/201916/05/2019Extension 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
79NCT03836716September 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: ArimoclomolOrphazymeNULLEnrolling by invitation18 YearsN/AAll231Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom
80EUCTR2019-000826-22-SE17/09/201902/08/2019Study 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2018-004180-31-GB05/09/201901/11/2019An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
82EUCTR2019-000374-39-PL05/09/201922/05/2019Extension 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Italy;Switzerland;United Kingdom;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Sweden
83NCT04081714September 4, 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
84NCT03474263September 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
85EUCTR2019-000374-39-NL27/08/201929/05/2019Extension 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
86EUCTR2018-004180-31-AT22/08/201903/05/2019An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
87EUCTR2018-004180-31-FI15/08/201925/04/2019An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
88NCT03508453August 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
89EUCTR2019-000374-39-ES07/08/201911/06/2019Extension 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
90NCT04055623August 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 SystemMassachusetts 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT03883581July 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 AssociationRecruiting18 Years90 YearsAll40Phase 1/Phase 2United States
92ChiCTR19000245202019-07-222019-07-13Split-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
93EUCTR2019-000374-39-GB15/07/201909/05/2019Extension 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
94NCT03948178June 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 PharmaNULLActive, not recruiting18 Years120 YearsAll450Phase 3Spain
95EUCTR2018-004180-31-DE17/06/201912/04/2019An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
96NCT04140136June 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
97EUCTR2018-002722-22-BE06/06/201919/02/2019Safety 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Netherlands;United Kingdom
98NCT03945279May 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: PlaceboBiogenNULLRecruiting18 YearsN/AAll48Phase 1United States
99EUCTR2018-002722-22-GB20/05/201928/02/2019Safety 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
100EUCTR2018-004180-31-ES16/05/201912/04/2019An 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
Inclusion_
agemax
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size
PhaseCountries
101NCT03929068May 13, 201910/4/2019Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral SclerosisSinemet in ALS and PLSAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: carbidopa-levodopa;Drug: Placebo Oral TabletWashington University School of MedicineNULLSuspended18 YearsN/AAll15Phase 1United States
102EUCTR2018-004180-31-BE29/04/201915/03/2019An 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
103NCT04176224April 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
104NCT03693781April 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 HeartRecruiting18 Years80 YearsAll54Phase 2Italy
105NCT02437110April 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)NULLRecruiting18 YearsN/AAll200Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
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agemax
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gender
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size
PhaseCountries
106JPRN-JMA-IIA0041929/03/201929/03/2019Phase 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
107JPRN-jRCT205119000129/03/201901/04/2019Phase 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
108NCT03705390March 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;NeuregenixRecruiting18 YearsN/AAll15Phase 2United Kingdom
109JPRN-UMIN0000362952019/03/2926/03/2019Phase 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.Recruiting20years-old80years-oldMale and Female24Phase 1Japan
110EUCTR2017-002754-36-FR27/03/201927/11/2018Effects 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
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size
PhaseCountries
111NCT03800524February 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 CommissionRecruiting18 Years80 YearsAll440Phase 3Belgium;France;Germany;Ireland;Italy;Netherlands;United Kingdom
112NCT03792490February 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 GoettingenNULLRecruiting18 YearsN/AAll120Phase 2France;Germany;Switzerland
113NCT03293069January 30, 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, FranceRecruiting18 Years75 YearsAll240Phase 2/Phase 3France
114NCT03690791January 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
115NCT03757351December 28, 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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size
PhaseCountries
116NCT03755167December 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
117JPRN-JMA-IIA0039705/12/201826/11/2018Phase 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).Satoru MorimotoNULLCompleted>=20 YEARS<=80 YEARSBOTH20Phase 1/2Japan
118EUCTR2018-000137-13-BE04/12/201813/09/2018A 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]
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
231 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Poland;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
119NCT03793868December 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
120NCT03944447December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Chronic 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, MedicalOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
121EUCTR2018-000137-13-NL21/11/201818/09/2018A 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
122EUCTR2018-000137-13-GB19/11/201807/09/2018A 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]
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
231 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
123NCT02118727November 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 CenterNULLRecruiting18 Years85 YearsAll90Phase 2United States
124NCT03580616October 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;Possible Amyotrophic SclerosisDrug: L-SerineElijah W. StommelBrain Chemistry Labs, Institute for EthnomedicineRecruiting18 YearsN/AAll50Phase 2United States
125EUCTR2018-000137-13-SE22/10/201807/09/2018A 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2018-000137-13-ES19/10/201809/10/2018A 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
127EUCTR2018-000137-13-PL18/10/201802/10/2018A 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]
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
231 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Poland;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
128EUCTR2018-000137-13-FR05/10/201806/09/2018A 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]
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
231 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;France;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
129EUCTR2018-000586-37-IE13/09/201808/05/2018A 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Canada;Spain;Ireland;Australia;Netherlands
130EUCTR2017-004459-21-IT11/09/201807/11/2018Study 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: LLTClassification code 10052889Term: ALSSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT03626012September 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: PlaceboBiogenNULLActive, not recruiting18 YearsN/AAll114Phase 1United States;Canada;Netherlands;Switzerland;United Kingdom
132EUCTR2016-003225-41-DE06/09/201815/09/2017Long-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: 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]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
144 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;European Union;Canada;Australia;Germany;Japan
133EUCTR2017-002754-36-NL30/08/201822/05/2018Effects 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Netherlands;Germany;Sweden
134EUCTR2018-000586-37-NL15/08/201804/06/2018A 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Canada;Spain;Ireland;Australia;Netherlands
135NCT03613571August 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2018-000668-28-GB09/08/201825/06/2018A 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]
University of BirminghamNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited Kingdom
137NCT03652805August 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
138NCT03491462July 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 capsuleOrphazymeNULLActive, not recruiting18 YearsN/AAll231Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom;Denmark
139EUCTR2018-000586-37-ES19/07/201823/05/2018A 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Canada;Spain;Ireland;Australia;Netherlands
140NCT03506425June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03505021June 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
142NCT03472950June 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
143NCT03537807June 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
144EUCTR2017-002754-36-BE15/05/201828/02/2018Effects 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
145EUCTR2017-005065-47-SE15/05/201819/03/2018A 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]TikoMed ABNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2018-000142-18-FI09/05/201808/05/2018Feasibility 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: 20.1Level: LLTClassification code 10036704Term: Primary lateral sclerosisSystem 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
147EUCTR2017-002754-36-IE08/05/201825/01/2018Effects 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
148EUCTR2017-002754-36-GB04/05/201830/01/2018Effects 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
149EUCTR2017-002754-36-ES29/04/201814/03/2018Effects 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;Canada;Belgium;Australia;Germany;Netherlands;Sweden
150EUCTR2017-002754-36-FI19/04/201828/02/2018Effects 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2017-002754-36-AT17/04/201808/03/2018Effects 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: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
152NCT03482050April 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: AstroRxKadimastemNULLRecruiting18 Years70 YearsAll21Phase 1/Phase 2Israel
153NCT03334786April 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
154NCT03679975April 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
155NCT03488524March 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 InstituteEnrolling by invitationN/AN/AAll132Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT03457753March 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
157NCT03520517February 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
158NCT03427086January 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 CenterNULLRecruiting18 Years80 YearsAll30Phase 2Lebanon
159NCT03136809January 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
160NCT03377309December 1, 201714/12/2017Safety 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 CenterNULLRecruiting18 Years80 YearsAll20Phase 2Lebanon
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT03548311November 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
162NCT03338114November 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
163NCT03272503October 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
164NCT03268603October 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 MinnesotaRecruiting18 YearsN/AAll60Phase 2United States
165NCT03487263October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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agemax
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PhaseCountries
166NCT03168711October 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
167EUCTR2016-003225-41-GB20/09/201702/06/2017Long-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 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
183 Human pharmacology (Phase 1): yes Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Australia;Germany;Japan;Italy;United Kingdom;Sweden
168NCT03359538September 19, 20178/11/2017Rapamycin Treatment for ALSRapamycin (Sirolimus) Treatment for Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Rapamycin;Drug: Placebo Oral TabletAzienda Ospedaliero-Universitaria di ModenaUniversity of Modena and Reggio Emilia;Azienda Ospedaliero Universitaria Maggiore della Carita;IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy;University of Turin, Italy;Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta;Azienda Ospedaliera Niguarda Cà Granda;Fondazione Salvatore Maugeri;University of PadovaActive, not recruiting18 Years75 YearsAll63Phase 2Italy
169EUCTR2016-002629-13-BE04/09/201721/04/2017An 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: 19.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
170NCT03280056August 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: PlaceboBrainstorm-Cell TherapeuticsCalifornia Institute for Regenerative Medicine (CIRM)Active, not recruiting18 Years60 YearsAll261Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2016-002629-13-PT28/08/201704/05/2017An 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
172NCT03707795August 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
173NCT03237741August 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
174NCT03160898July 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
175JPRN-UMIN0000293082017/07/1830/09/2018Study 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. Amyotrophic lateral sclerosisFebuxostat 20 mg, Inosine 500 mg, twice a day for 14 daysTeikyo UniversityNULLComplete: follow-up complete20years-old80years-oldMale and Female3Not appl1cableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2016-002399-28-IT14/07/201723/01/2018Rapamycin (Sirolimus) treatment for amyotrophic lateral sclerosisRapamycin (Sirolimus) treatment for amyotrophic lateral sclerosis - RAP.ALS definite or probable ALS
MedDRA version: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
177NCT03186040July 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
178JPRN-jRCTs03118017307/07/201701/03/2019Open-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 applicableBoth30Japan
179NCT03127514June 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
180NCT03068754June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
181NCT03039673June 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 NimesNULLActive, not recruiting18 Years75 YearsAll304Phase 2France;United Kingdom
182EUCTR2016-002629-13-NL07/06/201714/03/2017An 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: 19.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
183EUCTR2016-002629-13-GB05/06/201709/02/2018An 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
184JPRN-UMIN0000274762017/06/0101/06/2017Open-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 continuing20years-oldNot applicableMale and Female30Not selectedJapan
185NCT03324399June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT02962050May 31, 20174/11/2016Delineating Swallowing Impairment and Decline in ALSDelineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALSAmyotrophic Lateral SclerosisProcedure: Videofluoroscopic Swallowing Study (VFSS);Device: Voluntary Peak Cough Flow Testing;Device: Iowa Oral Performance Instrument;Drug: Capsaicin Challenge;Device: Pulmonary Function Testing;Other: Eating Assessment Tool 10;Other: The Center for Neurologic Study Bulbar Function ScaleUniversity of FloridaNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting18 Years90 YearsAll110United States
187EUCTR2016-002629-13-FR22/05/201716/05/2017An 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;France;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
188NCT03019419April 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 UniversityNULLActive, not recruiting40 Years78 YearsAll60Phase 2Japan
189JPRN-UMIN0000256142017/04/2401/02/2017Perampanel 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 continuing40years-old78years-oldMale and Female60Phase 2Japan
190NCT03103815April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2016-002629-13-ES12/04/201710/03/2017An 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: 19.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
192EUCTR2016-003225-41-BE10/04/201710/04/2017Long-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: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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;European Union;Canada;Belgium;Australia;Germany;United Kingdom;Japan;Korea, Republic of
193NCT03049046April 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
194NCT02943850April 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
195NCT03272802March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT03070119March 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.Enrolling by invitation18 YearsN/AAll183Phase 3United States;Belgium;Canada;France;Germany;Italy;Japan;New Zealand;United Kingdom
197JPRN-UMIN0000262212017/03/0201/03/2017Safety 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
198EUCTR2016-002629-13-IE28/02/201725/11/2016An 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
199NCT03214146February 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
200NCT03020797December 201615/12/2016A 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.Unknown status18 Years80 YearsAll60N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2014-005413-23-IE30/11/201610/09/2015Ventilatory 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
202NCT03456882November 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 ONLUSActive, not recruiting18 Years80 YearsAll142Phase 2United States;Italy
203JPRN-UMIN0000248542016/11/1616/11/2016Clinical 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 appl1cableJapan
204NCT02870634November 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
205NCT02936635October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT02868580October 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
207NCT02781454October 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
208JPRN-UMIN0000243122016/09/2025/05/2017Studies 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. 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
209NCT03067857September 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
210NCT02872142August 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT02794857August 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
212EUCTR2015-005347-14-GB25/08/201609/05/2016Efficacy 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
213EUCTR2015-004098-33-DE16/08/201607/12/2015An 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 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
183 Human pharmacology (Phase 1): yes Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Denmark;Australia;Germany;Japan;Italy;United Kingdom;Korea, Republic of;Sweden
214EUCTR2015-004098-33-SE29/06/201627/11/2015An 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: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
215NCT03114215June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03876002June 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
217NCT03835507June 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
218EUCTR2015-005810-31-FR03/06/201624/10/2016Effect 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]
MEDDAY PHARMACEUTICALSNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance
219NCT02655614May 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
220EUCTR2014-005413-23-IT30/05/201616/02/2018Ventilatory 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2014-005413-23-DE20/05/201621/08/2015Ventilatory 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
222NCT03241784May 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
223EUCTR2014-005413-23-PT09/05/201603/02/2016Ventilatory 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
224NCT02714036May 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
225NCT04454840May 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT03204500May 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
227EUCTR2014-005413-23-BE20/04/201626/02/2016Ventilatory 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
228EUCTR2015-004098-33-GB18/04/201610/12/2015An 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: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
229EUCTR2014-005413-23-NL06/04/201630/11/2015Ventilatory 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: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
230NCT02710162April 201629/2/2016Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)Determination of Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDevice: Micro Mouth Pressure Meter;Device: Iowa Oral Performance Instrument;Device: Electrical Impedance Myography;Drug: Capsaicin;Procedure: Videofluoroscopic Swallowing Study;Procedure: Pulmonary Function Testing;Other: Swallowing Related Quality of Life Questionnaire;Other: Functional Oral Intake Scale;Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised;Other: Eating Assessment Tool-10;Other: Communicative Effectiveness Survey;Other: The Center for Neurologic Studies Bulbar Function ScaleUniversity of FloridaNULLCompleted21 Years85 YearsAll21Early Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
231NCT02709330April 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
232NCT02710110April 201626/2/2016Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDevice: PowerLung trainer;Device: Micro Mouth Pressure Meter;Procedure: Pulmonary Function Testing;Procedure: Videofluoroscopic swallowing study;Other: Swallowing Quality of Life Questionnaire;Device: Iowa Oral Pressure Instrument;Drug: CapsaicinUniversity of FloridaALS AssociationCompleted21 Years85 YearsAll50Early Phase 1United States
233EUCTR2015-004098-33-BE01/03/201614/01/2016An 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 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
144 Human pharmacology (Phase 1): yes Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Australia;Germany;Japan;Italy;United Kingdom;Sweden
234EUCTR2014-005367-32-IT29/02/201617/03/2017Clinical 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: 19.1Level: PTClassification code 10028003Term: Motor neurone diseaseSystem 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
235EUCTR2014-005413-23-ES09/02/201610/12/2015Ventilatory 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: 18.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT02623699January 20, 201624/11/2015An 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 MutationAmyotrophic Lateral SclerosisDrug: BIIB067;Other: PlaceboBiogenIonis Pharmaceuticals, Inc.Recruiting18 YearsN/AAll183Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;United Kingdom;Sweden
237NCT02460679January 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
238EUCTR2014-005413-23-GB01/12/201527/08/2015Ventilatory 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]
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
239ChiCTR-IPR-150073652015-11-042015-11-03A 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
240EUCTR2014-004567-21-NL04/11/201504/08/2015Effects 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: 18.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
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PhaseCountries
241NCT02559869November 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
242NCT02881489November 201522/4/2016Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Patients With Amyotrophic Lateral SclerosisEvaluation of Mesenchymal Stem Cell Culturing Protocols in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisOther: Biological: Cell-based therapyUniversity of Warmia and MazuryNULLEnrolling by invitation18 Years65 YearsBoth30Phase 1NULL
243NCT02881476November 201522/4/2016Therapeutic Treatment of Amyotrophic Lateral SclerosisApplication of Wharton's Jelly-derived Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisOther: Biological: Cell-based therapyUniversity of Warmia and MazuryNULLEnrolling by invitation18 Years65 YearsBoth30Phase 1NULL
244NCT02469896November 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
245NCT03296501October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246JPRN-UMIN0000191112015/10/0101/10/2015CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. 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
247NCT02525471October 201512/8/2015A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)ALSDrug: RNS60Sabrina Paganoni, M.D.NULLCompleted18 Years80 YearsAll24Phase 1United States
248EUCTR2014-004567-21-DE22/09/201509/03/2015Effects 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: 19.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
249EUCTR2010-024423-24-NL21/09/201509/09/2015Evaluation 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: 19.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
250NCT02496767September 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT02059759September 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
252EUCTR2015-001431-20-NL17/08/201521/04/2015Trial 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: 18.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
253NCT02851914July 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
254NCT02487407July 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
255EUCTR2014-004567-21-IE05/06/201505/03/2015Effects 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: 19.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT02450552June 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
257EUCTR2014-004567-21-GB27/05/201510/03/2015Effects 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]
Orion Corporation Orion PharmaNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noIreland;Netherlands;Germany;United Kingdom
258EUCTR2010-024423-24-IT05/05/201504/02/2014Evaluation 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: 18.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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 SCIENCENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
381Portugal;Serbia;Slovakia;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Romania;Germany
259NCT02116634May 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
260NCT02987413April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2010-024423-24-HU21/04/201531/10/2014Evaluation 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: 17.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2/3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Netherlands;Germany
262EUCTR2010-024423-24-PT10/04/201503/11/2014Evaluation 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]
ABScienceNULLNot Recruiting Female: yes
Male: yes
381 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
263NCT02463825April 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
264EUCTR2010-024423-24-GR06/03/201521/11/2013Evaluation 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: 17.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
265NCT02405403March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266JPRN-UMIN0000163522015/02/0101/02/2015The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial amyotrophic lateral sclerosisedaravoneEhime University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Phase 1,2Japan
267NCT02306590February 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
268NCT02414230February 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
269NCT02288091January 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
270NCT02269436January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271ChiCTR-IOR-140056742014-12-302014-12-09Open 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
272NCT02479802November 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
273NCT02286011November 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
274JPRN-UMIN0000150542014/09/2104/09/2014An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis 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
275EUCTR2012-002099-15-SE15/09/201401/08/2014Safety 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: 17.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2014-002228-28-IT01/09/201412/06/2014STEMALS-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
277NCT02238626September 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
278NCT02492516September 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
279NCT01999803September 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
280NCT02236065August 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
281EUCTR2011-004801-25-ES16/07/201411/01/2013CLINICAL 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: 15.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
282NCT02152449July 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 NUTRICIAActive, not recruiting18 YearsN/AAll229N/AFrance
283NCT02290886July 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 AvanzadasActive, not recruiting18 YearsN/AAll52Phase 1/Phase 2Spain
284NCT03367650May 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
285EUCTR2013-004842-40-ES09/05/201407/03/2014Pilot 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: 16.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT02017912May 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
287EUCTR2010-024423-24-SK07/04/201405/12/2013Evaluation 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]
ABScienceNULLNot Recruiting Female: yes
Male: yes
381 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Serbia;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
288NCT02166944April 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
289NCT01759784March 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
290NCT02039401February 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT02645461January 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
292NCT01786603November 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
293NCT01884571October 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
294JPRN-UMIN0000114942013/09/0202/09/2013Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling 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 appl1cableJapan
295NCT01935518September 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT02164253September 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
297NCT01771640August 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
298NCT01854294August 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
299NCT01786174August 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
300NCT01849770July 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT01906658July 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
302EUCTR2012-004987-23-ES12/06/201316/05/2013A 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: 16.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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 IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2France;United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
303NCT01879241June 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
304NCT01811355May 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
305EUCTR2012-004987-23-DE29/04/201317/01/2013A 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: 16.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2011-004482-32-DE10/04/201321/12/2012Efficacy, 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
307NCT02588677April 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
308NCT01806857April 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
309EUCTR2011-004798-99-DE27/02/201327/12/2012Safety 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: 14.1Level: LLTClassification code 10036704Term: Primary lateral sclerosisSystem 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
310EUCTR2011-006254-85-ES08/02/201309/08/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311EUCTR2012-004987-23-IE08/02/201330/11/2012A 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
312EUCTR2010-024423-24-ES29/01/201329/11/2012Evaluation 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
313EUCTR2012-004987-23-GB24/01/201312/12/2012A 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]
Cytokinetics IncNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
314EUCTR2012-003349-13-DE15/01/201312/12/2012A 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
315EUCTR2012-003349-13-NL15/01/201312/11/2012A 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316NCT01759797January 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
317NCT01835782January 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
318NCT01776970January 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
319EUCTR2012-003349-13-GB19/12/201218/12/2012A 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]
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
294 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Australia;Germany;Netherlands;Italy;Japan;United Kingdom;Korea, Republic of
320EUCTR2012-003349-13-FR17/12/201220/06/2013A 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]
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
294 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;France;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2012-003349-13-BE06/12/201202/10/2012A 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: 15.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
322EUCTR2012-003349-13-IT03/12/201211/12/2012a 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
323NCT01753076December 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
324NCT01777646December 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
325NCT01825551November 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326NCT01160263October 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
327NCT01709149October 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
328NCT01933321September 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
329EUCTR2011-006119-70-DE31/08/201220/06/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
330EUCTR2011-006119-70-NL30/08/201214/06/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331EUCTR2011-006119-70-BE13/08/201214/06/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
332EUCTR2011-006119-70-GB10/08/201218/06/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
333EUCTR2011-006119-70-IE03/08/201207/06/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
334EUCTR2011-006119-70-ES27/07/201211/06/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
335NCT01622088June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336EUCTR2011-006119-70-SE15/05/201219/04/2012Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
337NCT01609283May 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
338EUCTR2011-000362-35-CZ29/03/201205/04/2011Safety 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: 17.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
339NCT01536249March 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
340NCT01565395March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341NCT01551940February 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
342NCT01511029January 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
343NCT03828123January 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
344NCT01492686December 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
345NCT01640067December 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT01232738December 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
347EUCTR2010-023161-21-FR23/11/201106/09/2011Sclérose 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: 14.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
348NCT01449578November 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
349NCT01486849November 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
350JPRN-UMIN0000064232011/10/0101/10/2011The clinical trial to assess efficacy of mexiletine for 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351EUCTR2011-001329-26-IT03/08/201117/11/2011Erythropoietin 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: 14.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
352NCT01424163August 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 BiosciencesBiogen IdecCompleted18 Years60 YearsBoth56Phase 1United Kingdom
353NCT01424176July 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
354EUCTR2010-022818-19-ES09/06/201121/02/2011A 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: 12.1Level: LLTClassification code 10002026Term: 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
804Germany;United Kingdom;Netherlands;Ireland;Spain;Sweden
355EUCTR2010-022818-19-BE07/06/201124/01/2011Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356NCT01051882June 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
357NCT01378676June 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
358EUCTR2010-022818-19-NL24/05/201111/05/2011Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
359EUCTR2010-022818-19-DE12/05/201121/02/2011Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
360EUCTR2010-021179-10-GB18/04/201131/01/2011An 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: 14.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2010-022818-19-IE08/04/201115/02/2011Clinical 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: 15.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
362EUCTR2010-022818-19-SE07/04/201109/02/2011Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
363EUCTR2010-022818-19-GB22/03/201110/01/2011Clinical 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: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem 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
364EUCTR2010-021179-10-DE15/03/201112/11/2010An 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: 12.1Level: LLTClassification code 10052889Term: 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
365NCT01257581March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366NCT00876772March 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
367NCT01281189March 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
368NCT02880033February 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
369NCT01363401February 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
370NCT01277315February 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
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
371NCT01281631February 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
372EUCTR2010-021179-10-BE28/01/201105/01/2011An 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: 12.1Level: LLTClassification code 10052889Term: 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
373EUCTR2010-022808-40-IT13/01/201102/02/2011A 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: 9.1Level: PTClassification 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
374NCT03085706October 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
375NCT01285583October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
376NCT01259050October 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
377EUCTR2010-020257-13-IT30/07/201005/07/2010A 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: 9.1Level: SOCClassification 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
378NCT01091142July 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
379EUCTR2008-003982-21-FR10/06/201014/01/2010Etude 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: 8.1Level: PTClassification code 10002026Term: 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
380NCT01142856June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
381EUCTR2009-016066-91-IT10/03/201017/11/2009SAFETY 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: 9.1Level: SOCClassification 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
382NCT01082653March 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
383NCT01089010March 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
384NCT02193893January 201016/7/2014Biological Treatment of Amyotrophic Lateral SclerosisSafety/Efficacy Study for the Biological Treatment of Amyotrophic Lateral Sclerosis With Autologous Stem/Progenitor CellsAmyotrophic Lateral SclerosisOther: Biological: Cell-based therapeutics;Other: Symptomatic treatment of ALSPomeranian Medical University SzczecinNULLEnrolling by invitation18 Years65 YearsBoth50Phase 1Poland
385NCT01041222January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
386NCT01016522November 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
387NCT01083667November 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
388NCT00983983October 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
389NCT00982150September 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
390EUCTR2008-007320-25-ES10/08/200916/07/2009Phase 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: 9.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis
Product Name: TRO19622
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
470Phase 2/3United Kingdom;Germany;Belgium;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
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391JPRN-UMIN0000022762009/08/0101/08/2009Developmental research of communication devices based on the brain machine interface using electroencephalograms 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 appl1cableJapan
392EUCTR2008-007320-25-GB24/07/200914/04/2009 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
TROPHOSNULLNot Recruiting Female: yes
Male: yes
470 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Spain;Belgium;Germany;United Kingdom
393NCT00931944July 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
394NCT00965497July 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
395EUCTR2008-007320-25-DE24/06/200918/02/2009Phase 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: 9.1Level: LLTClassification code 10002026Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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PhaseCountries
396EUCTR2008-006722-34-IT23/06/200911/12/2008Multicentric 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: 9.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis
Trade Name: CARBOLITHIUM
INN or Proposed INN: Lithium
ISTITUTO SUPERIORE DI SANITA`NULLNot RecruitingFemale: yes
Male: yes
Italy
397EUCTR2008-006224-61-ES12/06/200904/05/2009Ensayo 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: 9Level: PTClassification code 10002026Term: 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
398EUCTR2008-007320-25-BE08/06/200928/04/2009Phase 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: 9.1Level: LLTClassification code 10002026Term: 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
399NCT00925847June 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
400NCT01384162June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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gender
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size
PhaseCountries
401EUCTR2008-005106-38-ES14/05/200926/02/2009ENSAYO 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: 9.1Level: LLTClassification code 10002026Term: 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
402NCT00875446May 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
403NCT00868166April 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
404NCT00886977April 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
405EUCTR2009-010060-41-IT24/02/200906/03/2009Evaluation 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: 9.1Level: LLTClassification code 10002026Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
406EUCTR2008-006891-31-GB17/02/200928/07/2010A 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: 9.1Level: LLTClassification code 10002026Term: 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
407EUCTR2008-007320-25-FR17/02/200916/03/2009Phase 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: 9.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
470Phase 2/3United Kingdom;Germany;Belgium;France;Spain
408JPRN-UMIN0000085272009/01/0125/07/2012Study of efficacy and safety of NDDPX08 in ALS patients 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
409NCT00818389January 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
410NCT00706147January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411NCT01984814December 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
412NCT00800501December 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
413NCT02242071December 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
414EUCTR2007-003775-39-DE29/10/200809/09/2008Randomised, 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
415EUCTR2008-002062-62-NL14/10/200802/06/2008A 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: 9.1Level: PTClassification code 10052653Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416EUCTR2008-003707-32-FR09/10/200822/08/2008Etude 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: 8.1Level: PTClassification code 10002026Term: 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
417EUCTR2008-002062-62-FR22/09/200819/06/2008A 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: 9.1Level: PTClassification code 10052653Term: 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, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
418EUCTR2008-002062-62-HU17/09/200817/12/2008A 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: 9.1Level: PTClassification code 10052653Term: 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
419EUCTR2008-002110-22-NL16/09/200805/08/2008A 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: 9.1Level: LLTClassification code 10052889Term: 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
420EUCTR2008-002062-62-DE08/09/200819/01/2009A 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: 9.1Level: PTClassification code 10052653Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421NCT00696332September 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
422NCT00748501September 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
423EUCTR2008-002062-62-ES13/08/200826/06/2008Estudio 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: 9.1Level: PTClassification code 10052653Term: 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, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
424EUCTR2008-002062-62-BE31/07/200811/07/2008A 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: 9.1Level: PTClassification code 10052653Term: 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
425EUCTR2008-002062-62-IT16/06/200827/06/2008A 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: 9.1Level: LLTClassification code 10052653Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426NCT00919555June 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
427NCT00877604June 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
428NCT00694941June 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
429EUCTR2007-004723-37-DE16/05/200829/01/2008A 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: 9.1Level: LLTClassification code 10002026Term: 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
430EUCTR2007-004723-37-GB12/05/200815/02/2008A 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: 9.1Level: LLTClassification code 10002026Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT00690118May 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
432NCT00790582May 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
433EUCTR2007-004723-37-BE23/04/200831/01/2008A 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: 9.1Level: LLTClassification code 10002026Term: 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
434EUCTR2006-005410-13-DE22/04/200821/01/2008EFFICACY, 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: 9.1Level: LLTClassification code 10002026Term: 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
435EUCTR2007-004723-37-FR15/04/200806/02/2008A 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: 9.1Level: LLTClassification code 10002026Term: 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
273Phase 2United Kingdom;Germany;Belgium;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436EUCTR2008-001094-15-IT10/03/200810/03/2008SINGLE-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: 9.1Level: LLTClassification code 10002026Term: 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
437NCT00647296March 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
438EUCTR2007-001592-10-IT15/02/200815/01/2008A 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: 9.1Level: LLTClassification code 10002026Term: 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
439NCT00445172February 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
440EUCTR2007-002117-39-ES31/01/200812/02/2008MEMANTINA (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: 9.1Level: LLTClassification code 10002026Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT00753571January 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
442NCT00561366January 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
443NCT00573443December 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
444EUCTR2007-004165-17-IT25/09/200715/10/2007Efficacy 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: 6.1Level: PTClassification code 10002026
INN or Proposed INN: CeftriaxoneAZIENDA OSPEDALIERA PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
445NCT00600873August 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446EUCTR2007-002379-16-IT29/05/200709/11/2007MULTICENTER 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: 6.1Level: PTClassification 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
447EUCTR2006-002660-26-NL17/04/200703/01/2007A 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: 8.1Level: LLTClassification code 10002026Term: 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
448NCT00444613April 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
449NCT00409721March 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
450NCT00635960March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
451EUCTR2006-002660-26-IT01/02/200710/11/2006A 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: 8.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506ONO PHARMA UK LTDNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
452EUCTR2006-002660-26-GB08/01/200720/09/2006A 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: 8.1Level: LLTClassification code 10002026Term: 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
453NCT00424463January 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
454EUCTR2006-002660-26-DE20/12/200619/01/2007A 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: 8.1Level: LLTClassification code 10002026Term: 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
455EUCTR2006-002660-26-FR12/12/200610/10/2006A 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: 8.1Level: LLTClassification code 10002026Term: 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.,LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456NCT00397423December 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
457NCT00372879December 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
458NCT00415519December 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
459EUCTR2006-002660-26-AT13/11/200606/11/2006A 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: 8.1Level: LLTClassification code 10002026Term: 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
460EUCTR2006-002660-26-BE13/11/200628/09/2006A 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: 8.1Level: LLTClassification code 10002026Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461NCT00403104November 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
462EUCTR2006-001688-49-GB14/08/200628/04/2006A 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
TEVA Pharmaceutical Industries. Ltd.NULLNot Recruiting Female: yes
Male: yes
366 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noBelgium;Germany;Italy;United Kingdom
463NCT00326625July 31, 200616/5/2006Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)A Multinational, Multicenter, 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)Amyotrophic Lateral SclerosisDrug: 40 mg glatiramer acetate;Drug: PlaceboTeva Pharmaceutical Industries, Ltd.NULLCompleted18 Years70 YearsAll366Phase 2Belgium;France;Germany;Israel;Italy;United Kingdom
464EUCTR2006-001688-49-DE31/07/200624/05/2006A 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: 8.1Level: PTClassification 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
465NCT00355576July 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466NCT00349622July 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
467EUCTR2006-001688-49-BE26/06/200610/05/2006A 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: 8.1Level: PTClassification 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
468NCT00330681May 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