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 2. 筋萎縮性側索硬化症 [臨床試験数:322,薬物数:365(DrugBank:127),標的遺伝子数:154,標的パスウェイ数:57] 

Searched query = "Amyotrophic lateral sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT02478450December 202025 March 2019Study 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.Not recruiting18 YearsN/AAll30Phase 1/Phase 2
2NCT02988297February 202016 September 2019Nebulized RNS60 for the Treatment of Amyotrophic Lateral SclerosisNebulized RNS60 for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: RNS60;Drug: PlaceboRevalesio CorporationNot recruiting18 Years80 YearsAll140Phase 2
3NCT03651349January 202020 May 2019To 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.Not recruiting20 YearsN/AAll56Phase 1Taiwan
4NCT04098406December 201930 September 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 LtdNot recruiting40 Years80 YearsAll42Phase 2Australia
5NCT03127267November 201924 June 2019Efficacy 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 ScienceNot recruiting18 Years81 YearsAll495Phase 3Canada
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6NCT03843710October 30, 201930 September 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 recruiting35 Years75 YearsAll24Phase 2United States
7NCT04066244October 23, 20192 September 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 PharmaceuticalsNot recruiting18 Years75 YearsAll20Phase 2
8NCT03981536October 10, 201928 October 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 PharmaRecruiting18 YearsN/AAll18Phase 1Canada
9NCT04057898October 20199 September 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 an Open-Label Extension Phase in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: MN-166;Drug: placeboMediciNovaNot recruiting18 Years80 YearsAll230Phase 2/Phase 3
10NCT04082832September 30, 201911 November 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 LimitedRecruiting18 Years75 YearsAll80Phase 2/Phase 3Australia
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11NCT03836716September 19, 201930 September 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: ArimoclomolOrphazymeRecruiting18 YearsN/AAll231Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom
12NCT04081714September 4, 201930 September 2019Intermediate Expanded Access Protocol for ALSAn Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8Amyotrophic Lateral SclerosisDrug: CNM-Au8Clene NanomedicineMassachusetts General HospitalNot recruiting18 YearsN/AAllPhase 1United States
13NCT03474263September 1, 201925 March 2019IC14 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 BioscienceNot recruiting18 Years80 YearsAll0Phase 2Australia;United States
14NCT04090684September 201930 September 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.Not recruiting18 Years75 YearsAll30Phase 1United States
15NCT04055623August 8, 201930 September 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 ConsortiumRecruiting18 YearsN/AAll12Phase 2United States
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16NCT03883581July 25, 20194 November 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
17NCT03948178June 26, 201916 September 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 PharmaRecruiting18 Years120 YearsAll450Phase 3Spain
18NCT04140136June 17, 20194 November 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 MalayaRecruitingN/AN/AAll20Phase 2Malaysia
19NCT03945279May 30, 20194 November 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: PlaceboBiogenRecruiting18 YearsN/AAll40Phase 1United States
20JPRN-jRCTs04119002823/05/201922 July 2019Ivig for ALSIntravenous Immunoglobulin Therapy for Amyotrophic lateral sclerosis - ALSIvigAmyotrophic lateral sclerosis
ALS
Treatment of Intravenous immunoglobulin at a dose of 400 mg/kg/day for 5 days.Makoto MatsuiRecruiting>=30 age old<80 age oldBoth30N/Anone
No.TrialIDDate_
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21NCT03537807May 13, 201926 August 2019Expanded 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.Not recruiting18 YearsN/AAllPhase 2
22NCT03929068May 13, 201915 July 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 MedicineRecruiting18 YearsN/AAll15Phase 1United States
23JPRN-JMA-IIA0041929/03/201923 April 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 UniversityRecruiting>=20 YEARS<80 YEARSBOTH24Phase 1Japan
24JPRN-UMIN0000362952019/03/2916 July 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
25JPRN-jRCT205119000129/03/201922 July 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.
Haruhisa InoueRecruiting20 age old79 age oldBoth24Phase 1none
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26NCT03800524February 22, 201928 October 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
27NCT03792490February 20, 201925 March 2019Inhibition 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 GoettingenRecruiting18 YearsN/AAll120Phase 2Germany
28NCT03766321February 201918 December 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 FlorenceNot recruiting18 Years70 YearsAll42N/AItaly
29NCT03293069January 30, 20193 June 2019Conservative 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
30NCT03693781January 30, 201928 January 2019Colchicine 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 HeartNot recruiting18 Years80 YearsAll54Phase 2Italy
No.TrialIDDate_
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31NCT03690791January 9, 201925 February 2019Efficacy 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 (CannTrust CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease PatientsAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: CannTrust CBD Oil (capsule);Drug: Placebo (capsule)Gold Coast Hospital and Health ServiceCannTrust Inc.Recruiting25 Years75 YearsAll30Phase 3Australia
32NCT03757351December 28, 201830 September 2019Study 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: PlaceboDenali Therapeutics Inc.Recruiting21 Years80 YearsAll16Phase 1United States;Netherlands
33NCT03755167December 9, 201830 September 2019A 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.Recruiting18 Years75 YearsAll15Phase 2Israel
34JPRN-JMA-IIA0039705/12/20187 October 2019Phase 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 MorimotoNot Recruiting>=20 YEARS<=80 YEARSBOTH20Phase 1-2Japan
35NCT03793868December 4, 201814 January 2019Perampanel 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 ClinicRecruiting18 Years70 YearsAll24Early Phase 1United States
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36NCT03944447December 1, 20187 October 2019Outcomes Mandate National Integration With Cannabis as MedicineOutcomes Mandate National Integration With Cannabis as MedicineChronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar DisorderDrug: Cannabis, MedicalOMNI Medical Services, LLCRecruiting7 YearsN/AAll100000Phase 2United States
37EUCTR2018-000137-13-NL21/11/201828 February 2019A 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 SclerosisAmyotrophic Lateral Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ARIMOCLOMOL
CAS Number: 368860-21-3
Current Sponsor code: BRX-345
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Orphazyme A/SAuthorised Female: yes
Male: yes
231Phase 3France;United States;Canada;Poland;Belgium;Spain;Germany;Netherlands;Italy;United Kingdom;Switzerland;Sweden
38NCT02118727November 7, 201811 November 2019Therapy 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 CenterRecruiting18 Years85 YearsAll90Phase 2United States
39NCT03580616October 24, 201828 January 2019Tolerability 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
40EUCTR2017-004459-21-IT11/09/201812 November 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-ALSDefinite or probable amyotrophic lateral sclerosis
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: LLT Classification code 10052889 Term: ALS System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: COLCHICINA LIRCA - 1 MG COMPRESSE 60 COMPRESSE
Product Name: Colchicina
Product Code: Colchicina
Pharmaceutical Form: Tablet
INN or Proposed INN: COLCHICINA
CAS Number: 64-86-8
Current Sponsor code: Colchicina
Other descriptive name: COLCHICINA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENAAuthorisedFemale: yes
Male: yes
54Phase 2Italy
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41NCT03626012September 10, 20184 November 2019A 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: PlaceboBiogenNot recruiting18 YearsN/AAll80Phase 1United States;Canada;Netherlands;United Kingdom
42NCT03508453August 15, 20189 July 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 BioscienceNot recruiting18 Years75 YearsAll50Phase 2Australia
43NCT03652805August 1, 201830 September 2019A 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.Recruiting18 Years80 YearsAll15Phase 1/Phase 2Israel
44NCT03491462July 31, 201815 July 2019Arimoclomol in Amyotropic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Arimoclomol;Drug: Placebo oral capsuleOrphazymeNot recruiting18 YearsN/AAll231Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom;Denmark
45NCT03506425June 21, 201823 April 2019A 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 IncNot recruiting18 YearsN/AAll10Phase 1/Phase 2United States
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46NCT03472950June 11, 201824 June 2019Safety 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
47EUCTR2017-002754-36-BE15/05/201820 August 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 - REFALSAmyotrophic lateral sclerosis (ALS)
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
Pharmaceutical Form: Capsule
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Current Sponsor code: ODM-109
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Orion CorporationAuthorisedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Canada;Belgium;Australia;Germany;Netherlands;Sweden
48EUCTR2017-005065-47-SE15/05/20183 September 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 SclerosisAmyotrophic Lateral Sclerosis (ALS);Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: ILB
Product Code: ILB
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ILB
CAS Number: 9011-18-1
Other descriptive name: DEXTRAN SULFATE SODIUM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
TikoMed ABAuthorisedFemale: yes
Male: yes
15Phase 2Sweden
49EUCTR2018-000142-18-FI09/05/201821 May 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 careAmyotrophic lateral sclerosis (ALS)
MedDRA version: 20.1 Level: LLT Classification code 10036704 Term: Primary lateral sclerosis System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Dexdor
Pharmaceutical Form: Concentrate for concentrate for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Trade Name: Ketanest-S
Pharmaceutical Form: Infusion
INN or Proposed INN: ESKETAMINE
CAS Number: 33643-46-8
Turku University HospitalAuthorisedFemale: yes
Male: yes
20Phase 4Finland
50EUCTR2017-002754-36-ES29/04/201814 May 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 - REFALSAmyotrophic lateral sclerosis (ALS)
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
Pharmaceutical Form: Capsule
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Current Sponsor code: ODM-109
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Orion CorporationAuthorisedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Canada;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
51EUCTR2017-002754-36-FI19/04/201825 June 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 - REFALSAmyotrophic lateral sclerosis (ALS)
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
Pharmaceutical Form: Capsule
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Current Sponsor code: ODM-109
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Orion CorporationAuthorisedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Canada;Belgium;Australia;Germany;Netherlands;Sweden
52EUCTR2017-002754-36-AT17/04/201823 July 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 - REFALSAmyotrophic lateral sclerosis (ALS)
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Oral LEVOSIMENDAN
Product Code: ODM-109
Pharmaceutical Form: Capsule
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Current Sponsor code: ODM-109
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Orion CorporationAuthorisedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Canada;Belgium;Australia;Germany;Netherlands;Sweden
53NCT03482050April 12, 201820 August 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: AstroRxKadimastemRecruiting18 Years70 YearsAll21Phase 1/Phase 2Israel
54NCT03334786April 5, 201810 September 2018Study 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.Not recruiting18 YearsN/AAll3Phase 1/Phase 2United States
55NCT03679975April 4, 20184 February 2019Riluzole Oral Soluble Film Swallowing Safety in Amyotrophic Lateral SclerosisA Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Riluzole Oral Soluble film (ROSF) 50 mgAquestive TherapeuticsinVentiv Health Clinical;CovanceNot recruiting18 Years80 YearsAll9Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
56NCT03488524March 29, 201826 August 2019Open 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 InstituteRecruitingN/AN/AAll132Phase 2United States
57NCT03457753March 1, 201827 May 2019Riluzole 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;CovanceNot recruiting18 Years80 YearsAll0Phase 2United States
58NCT03520517February 2, 20182 September 2019Open-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 CorporationNot recruiting18 YearsN/AAll22Phase 1United States
59NCT03427086January 29, 201815 July 2019Safety 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 CenterRecruiting18 Years80 YearsAll30Phase 2Lebanon
60NCT03136809January 18, 201811 November 2019ALS 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 LimitedNot recruiting18 Years75 YearsAll28Phase 1/Phase 2Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
61NCT03377309December 1, 20178 January 2018Safety 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 CenterRecruiting18 Years80 YearsAll20Phase 2Lebanon
62NCT03548311November 1, 20172 July 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: saline solution;Drug: methylcobalaminUniversity of TokushimaEisai Co., Ltd.Recruiting20 YearsN/AAll128Phase 3Japan
63NCT03338114November 201729 January 2018Study 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.Not recruiting18 YearsN/AAll0Phase 1/Phase 2United States
64NCT03272503October 27, 201722 October 2019A 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
65NCT03268603October 10, 201723 April 2019Intrathecal 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
66NCT03168711October 1, 20173 December 2018Safety 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 FundRecruiting18 Years85 YearsAll30Phase 2United States
67NCT03487263October 1, 201725 March 2019Dose-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 HospitalNot recruiting18 Years75 YearsAll10Phase 1Australia
68NCT03359538September 19, 201716 December 2017Rapamycin Treatment for ALSRapamycin (Sirolimus) Treatment for Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Rapamycin;Drug: Placebo Oral TabletAzienda Ospedaliera - 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 PadovaRecruiting18 Years75 YearsAll63Phase 2Italy
69NCT03280056August 28, 20174 November 2019Safety 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)Not recruiting18 Years60 YearsAll261Phase 3United States
70NCT03707795August 21, 201725 March 2019Treatment 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 daysUniversity of KentuckyRecruiting20 Years80 YearsAll30Early Phase 1United States
No.TrialIDDate_
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71NCT03237741August 7, 201711 June 2018Bioavailability 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 ClinicalNot recruiting30 Years65 YearsFemale24Phase 1United Kingdom
72NCT03160898July 24, 201715 April 2019A 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: CK-2127107;Drug: PlaceboCytokineticsAstellas Pharma IncNot recruiting18 Years80 YearsAll458Phase 2United States;Australia;Canada;Ireland;Netherlands;Spain
73JPRN-UMIN0000293082017/07/182 April 2019Study 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 UniversityNot Recruiting20years-old80years-oldMale and Female3Not applicableJapan
74EUCTR2016-002399-28-IT14/07/201729 January 2018Rapamycin (Sirolimus) treatment for amyotrophic lateral sclerosisRapamycin (Sirolimus) treatment for amyotrophic lateral sclerosis - RAP.ALSdefinite or probable ALS
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: RAPAMUNE - 1 MG 100 COMPRESSE RIVESTITE IN BLISTER USO ORALE
Product Name: Rapamune
Pharmaceutical Form: Coated tablet
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENAAuthorisedFemale: yes
Male: yes
63Phase 2Italy
75NCT03186040July 13, 201726 August 2019Open-label Clinical Trial of Lacosamide in ALSOpen-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: LacosamideChiba UniversityRecruiting20 YearsN/AAll30Phase 1/Phase 2Japan
No.TrialIDDate_
enrollement
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76JPRN-jRCTs03118017307/07/201710 September 2019Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisamyotrophic lateral sclerosis
amyotrophic lateral sclerosis;G122
gradual increase of lacosamide from 100mg to 400mg for 4 weeksSatoshi KuwabaraRecruiting20ageunrestrictedBoth30Phase 1-2none
77NCT02588807July 201716 December 2017Food 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 CenterNot recruiting18 Years75 YearsAll10Phase 1
78NCT03068754June 22, 201728 October 2019Study 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: PlaceboMallinckrodtNot recruiting18 Years75 YearsAll143Phase 2/Phase 3United States;Argentina;Canada;Chile;Colombia;Mexico;Peru
79NCT03127514June 22, 201722 October 2019AMX0035 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 FoundationNot recruiting18 Years80 YearsAll132Phase 2United States
80NCT03039673June 19, 201711 November 2019MIROCALS: 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 NimesNot recruiting18 Years75 YearsAll304Phase 2France;United Kingdom
No.TrialIDDate_
enrollement
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PhaseCountries
81JPRN-UMIN0000274762017/06/0116 July 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 - Open-label clinical trial of lacosamide in ALSamyotrophic lateral sclerosisgradual increase of lacosamide from 100mg to 400mg for 4 weeksDepartment of Neurology Chiba University HospitalRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
82NCT03324399June 1, 201715 July 2019A 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 CenterNot recruiting18 YearsN/AAll5N/AUnited States
83NCT02962050May 31, 20174 November 2019Delineating Swallowing Impairment and Decline in ALSDelineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALSAmyotrophic Lateral SclerosisProcedure: Videofluoroscopic Swallowing Study (VFSS);Procedure: High Resolution Manometry;Other: DIGEST;Other: Penetration Aspiration Scale;Other: Normalized Residue Ratio Scale;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 YearsAll110N/AUnited States
84JPRN-UMIN0000256142017/04/242 April 2019Perampanel 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 UniversityNot Recruiting40years-old78years-oldMale and Female60Phase 2Japan
85NCT03019419April 24, 20175 November 2018Perampanel 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: placebo;Drug: PerampanelTokyo Medical UniversityNot recruiting40 Years78 YearsAll60Phase 2Japan
No.TrialIDDate_
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Last_Refreshed_
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86NCT03103815April 24, 201716 December 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
87NCT03049046April 7, 201716 December 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, LLCRecruiting18 Years64 YearsAll21Phase 1United States
88NCT02943850April 1, 201722 October 2018CNS10-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 MedicineNot recruiting18 YearsN/AAll18Phase 1United States
89NCT03272802March 16, 20178 April 2019Treatment 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 SciencesNot recruiting18 Years75 YearsAll20Phase 2/Phase 3Iran, Islamic Republic of
90NCT03070119March 8, 201726 August 2019Long-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.Recruiting18 YearsN/AAll48Phase 3United States;Belgium;Canada;Germany;United Kingdom
No.TrialIDDate_
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91JPRN-UMIN0000262212017/03/022 April 2019Safety of perampanel in patients with motor neuron diseaseamyotrophic lateral sclerosisOnce daily perampanel with dose escalation from 2mg to 8mg.Department of Neurology, Juntendo University School of MedicineNot Recruiting20years-oldNot applicableMale and Female15Phase 1Japan
92NCT03214146February 1, 201727 May 2019Safety/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.Not recruiting25 Years80 YearsAll6Phase 1Korea, Republic of
93NCT03020797December 201617 September 2018A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Placebo Oral Tablet;Drug: PerampanelStony Brook UniversityEisai Inc.Recruiting18 Years80 YearsAll60N/AUnited States
94NCT03456882November 18, 20164 November 2019The Effect of RNS60 on ALS BiomarkersThe Effect of RNS60 on ALS BiomarkersAmyotrophic Lateral SclerosisDrug: RNS60Mario Negri Institute for Pharmacological ResearchALS Association;Get out ONLUSRecruiting18 Years80 YearsAll142Phase 2United States;Italy
95JPRN-UMIN0000248542016/11/162 April 2019Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosisAmyotrophic Lateral Sclerosis (ALS)Edaravone treatment for ALS patientsOkayama universityRecruiting20years-old75years-oldMale and Female20Not applicableJapan
No.TrialIDDate_
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96NCT02870634November 16, 201611 November 2019Phase 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 LimitedNot recruiting18 Years75 YearsAll50Phase 1Australia
97NCT02781454October 201620 August 2018Mexiletine 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 HospitalNot recruiting18 YearsN/AAll60Phase 2United States
98NCT02868580October 20162 September 2019Safety 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 CentreNot recruiting18 Years75 YearsAll43Phase 2Australia
99NCT02936635October 201616 December 2017A 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: tirasemtivCytokineticsNot recruiting18 YearsN/AAll280Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom
100JPRN-UMIN0000243122016/09/202 April 2019Studies 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 ClinicNot Recruiting20years-old80years-oldMale and Female12Not selectedJapan
No.TrialIDDate_
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101NCT03067857September 201618 June 2018Autologous 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 ArabiaNot recruiting24 Years70 YearsAll40Phase 1/Phase 2
102NCT02794857August 29, 201611 June 2018Safety 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.Not recruiting21 Years80 YearsAll138Phase 2United States;Canada
103NCT02872142August 29, 201626 August 2019Efficacy 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, LLCNot recruiting19 Years69 YearsAll12Phase 2United States
104EUCTR2015-005347-14-GB25/08/201610 September 2018Efficacy 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 - MIROCALSAmyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Proleukin 18 MUI
Product Name: proleukin
Pharmaceutical Form: Solution for infusion in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Subcutaneous use
CHU DE NIMESAuthorisedFemale: yes
Male: yes
216Phase 2United Kingdom
105NCT03114215June 29, 201617 June 2019Effect 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 SANot recruiting25 Years80 YearsAll30Phase 2France
No.TrialIDDate_
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106NCT03876002June 28, 20168 April 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 NeuroImagingNot recruiting18 Years80 YearsAll23Phase 1United States
107NCT03835507June 20, 201625 February 2019Randomized, 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 HospitalRecruiting25 Years80 YearsAll64Phase 1/Phase 2Korea, Republic of
108EUCTR2015-005810-31-FR03/06/201631 October 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-ALSAmyotrophic lateral sclerosis
MedDRA version: 19.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MD1003
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BIOTIN
CAS Number: 58-85-5
Current Sponsor code: MD1003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
MEDDAY PHARMACEUTICALSAuthorisedFemale: yes
Male: yes
Phase 2France
109NCT02655614May 31, 201628 October 2019A 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.Not recruiting18 YearsN/AAll82Phase 1United States;Canada;Netherlands
110NCT03241784May 16, 201611 June 2018T-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, MDNot recruiting18 YearsN/AAll4Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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111NCT02709330April 201616 December 2017ALS 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.Not recruiting18 YearsN/AAll50Phase 2United States
112NCT02710110April 201625 February 2019Respiratory 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 AssociationNot recruiting21 Years85 YearsAll54Early Phase 1United States
113NCT02710162April 20168 January 2018Accurate 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 FloridaNot recruiting21 Years85 YearsAll21Early Phase 1United States
114NCT02714036March 20164 November 2019A 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 AssociatesNot recruiting18 YearsN/AAll35Phase 1/Phase 2United States
115EUCTR2014-005367-32-IT29/02/20163 April 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 - PROMISEAmiotrophic Lateral Sclerosis
MedDRA version: 19.1 Level: PT Classification code 10028003 Term: Motor neurone disease System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GUANABENZ ACETATO
Product Code: GUANA2015
Pharmaceutical Form: Tablet
INN or Proposed INN: GUANABENZ
CAS Number: 23256-50-0
Current Sponsor code: GUANA2015
Other descriptive name: GUANABENZ
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Product Name: RILUZOLO
Pharmaceutical Form: Tablet
INN or Proposed INN: RILUZOLO
CAS Number: 1744-22-5
Current Sponsor code: RILU2015
Other descriptive name: RILUZOLO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTAAuthorisedFemale: yes
Male: yes
208Phase 2Italy
No.TrialIDDate_
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116NCT02623699January 20, 201611 November 2019An 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/AAll144Phase 3United States;Australia;Belgium;Canada;France;Germany;Japan;United Kingdom;Italy;Sweden
117ChiCTR-IPR-150073652015-11-0418 April 2017A 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 Sclerosisamyotrophic 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 HospitalRecruitingBothTreatment group:147;Control group:147;Post-marketChina
118NCT02460679November 20153 September 2018Safety and Biomarker Study of EPI-589 in Subjects With ALSA Phase 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: EPI-589Edison Pharmaceuticals IncNot recruiting21 Years70 YearsAll20Phase 2United States
119NCT02469896November 201520 August 2018A 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.Not recruiting18 Years75 YearsAll22Phase 2United States
120NCT02559869November 201511 June 2018Imaging 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 AssociationRecruiting18 Years80 YearsAll200Phase 4United States
No.TrialIDDate_
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121NCT02881476November 20155 September 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 MazuryRecruiting18 Years65 YearsBoth30Phase 1
122NCT02881489November 20155 September 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 MazuryRecruiting18 Years65 YearsBoth30Phase 1
123NCT03296501October 13, 201516 December 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 WarsawRecruiting18 Years65 YearsAll30Phase 1Poland
124JPRN-UMIN0000191112015/10/012 April 2019CaHMB 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 CenterRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
125NCT02525471October 20155 March 2018A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)ALSDrug: RNS60Sabrina Paganoni, M.D.Not recruiting18 Years80 YearsAll24Phase 1United States
No.TrialIDDate_
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126NCT02496767September 3, 201520 August 2018Ventilatory 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 tablets;Drug: Riluzole 50 MGCytokineticsNot recruiting18 YearsN/AAll743Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom
127NCT02059759September 201513 June 2016Immuno-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 NimesNot recruiting18 Years75 YearsBoth36Phase 2France
128EUCTR2015-001431-20-NL17/08/20158 May 2017Trial 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 ALSAmytrophic Lateral Sclerosis
MedDRA version: 18.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rilutek 50 mg film-coated tablets
Product Name: Rilutek
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RILUZOLE
CAS Number: 1744-22-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Trobalt
Product Name: Trobalt
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RETIGABINE
CAS Number: 150812-12-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Centre for Human Drug ResearchNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
129NCT02851914July 21, 201521 January 2019SSRIs 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 UniversityRecruiting25 Years80 YearsAll40Early Phase 1United States
130NCT02487407July 201516 December 2017Effects 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 PharmaNot recruiting18 YearsN/AAll66Phase 2Germany;Ireland;Netherlands;United Kingdom
No.TrialIDDate_
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131EUCTR2014-004567-21-IE05/06/201521 August 2017Effects 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 - LEVALSAmyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength.
MedDRA version: 19.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-109 capsule 1 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Current Sponsor code: ODM-109
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Orion Corporation Orion PharmaNot RecruitingFemale: yes
Male: yes
70Phase 2Ireland;Netherlands;Germany;United Kingdom
132NCT02450552June 20151 October 2018Clinical 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 HospitalNot recruiting18 Years80 YearsAll65Phase 2United States
133NCT02116634May 201525 January 2016Mesenchymal 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, IranNot recruiting18 Years60 YearsBoth0Phase 1/Phase 2Iran, Islamic Republic of
134NCT02987413April 28, 201516 December 2017Escalated 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 CelularNot recruiting18 YearsN/AAll3Phase 1Brazil
135NCT02437110April 23, 20154 November 2019HERV-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)Recruiting18 YearsN/AAll200Phase 1United States
No.TrialIDDate_
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136NCT02463825April 20157 November 2016A 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 CalgaryNot recruiting18 YearsN/ABoth25Phase 2Canada
137NCT02405403March 201516 December 2017Microglial Activation Role In ALS (MARIA)Microglial Activation Role In ALS (MARIA)Amyotrophic Lateral SclerosisDrug: [18F]DPA-714 PETUniversity Hospital, ToursNot recruiting18 YearsN/AAll0Early Phase 1France
138JPRN-UMIN0000163522015/02/012 April 2019The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trialamyotrophic lateral sclerosisedaravoneEhime University HospitalNot Recruiting20years-oldNot applicableMale and Female10Phase 1,2Japan
139NCT02306590February 201511 March 2019Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDietary Supplement: Calogen;Dietary Supplement: PlaceboUniversity of UlmNot recruiting18 YearsN/AAll207N/AGermany
140NCT02414230February 20154 February 2019F 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 T807Washington University School of MedicineNot recruiting18 YearsN/AAll9Phase 2United States
No.TrialIDDate_
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141NCT02269436January 20158 February 2016A 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 ABNot recruiting18 Years75 YearsBoth11Phase 1Belgium;Netherlands
142NCT02288091January 201516 December 2017A 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 FundNot recruiting18 YearsN/AAll32Phase 1United States
143ChiCTR-IOR-140056742014-12-3018 April 2017Open 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 sclerosisamyotrophic lateral sclerosisChinese medicine :Jianpi Yifei Decoction ;Riluzole:Riluzole;Guangdong Province Traditional Chinese Medical HospitalNot Recruiting1880BothChinese medicine :30;Riluzole:30;OtherChina
144NCT02479802November 201426 February 2018Efficacy 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.Not recruiting18 Years70 YearsAll13Phase 2Spain
145JPRN-UMIN0000150542014/09/212 April 2019An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosisAmyotrophic 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 TokyoNot Recruiting20years-old35years-oldMale24Not selectedJapan
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146EUCTR2012-002099-15-SE15/09/201412 September 2016Safety 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 sclerosisAmyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pleconaril
Product Code: APO-P001
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PLECONARIL
CAS Number: 153168-05-9
Current Sponsor code: APO-P001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Copegus
Product Name: Ribavirin
Pharmaceutical Form: Capsule, hard
CAS Number: 36791-04-5
Other descriptive name: RIBAVIRIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Apodemus ABNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
147EUCTR2014-002228-28-IT01/09/20147 October 2014STEMALS-IIA double blind, placebo controlled, parallel groups, multicenter study on filgrastim in amyotrophic lateral sclerosis - STEMALS-IIAmyotrophic 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
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous use
Trade Name: MANNITOLO 18% LDB
Product Name: MANNITOLO 18%
Pharmaceutical Form: Injection
Trade Name: PERFALGAN
Product Name: PARACETAMOLO
Pharmaceutical Form: Injection
Università degli Studi di Torino e Azienda Ospedaliera Città della Salute e della Scienza di TorinoAuthorisedFemale: yes
Male: yes
90Italy
148NCT01999803September 20148 February 2016A 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 ABNot recruiting18 Years75 YearsBoth15Phase 1Belgium;Netherlands
149NCT02238626September 201410 December 2018Ibudilast (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: riluzoleMediciNovaCarolinas Healthcare SystemNot recruiting18 Years80 YearsAll71Phase 2United States
150NCT02492516September 201416 December 2017Intravenous 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 InstituteNot recruiting18 Years55 YearsAll19Phase 1Iran, Islamic Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
151NCT02236065August 201416 December 2017Combination 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.Not recruiting19 Years75 YearsAll10N/AKorea, Republic of
152EUCTR2011-004801-25-ES16/07/20145 August 2014CLINICAL 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 SCLEROSISamyotrophic lateral sclerosis
MedDRA version: 15.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: células troncales hematopoyéticas autólogas adultas extraidas de médula ósea
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: autologous bone marrow mononucleated cells
CAS Number: no available
Current Sponsor code: TCIM/ELA
Other descriptive name: autologous bone marrow mononucleated cells
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intramuscular use
Fundación Sanitaria para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO)AuthorisedFemale: yes
Male: yes
Phase 1/2Spain
153NCT02152449July 201415 July 2019Oral 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 NUTRICIANot recruiting18 YearsN/AAll229N/AFrance
154NCT02290886July 20149 September 2019A 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 AvanzadasNot recruiting18 YearsN/AAll52Phase 1/Phase 2Spain
155NCT03367650May 13, 201416 December 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-PitreRecruiting18 YearsN/AAll70N/AGuadeloupe;Martinique
No.TrialIDDate_
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PhaseCountries
156EUCTR2013-004842-40-ES09/05/20144 July 2016Pilot 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 ALSAmytrophic Lateral Sclerosis (ALS)
MedDRA version: 16.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Albutein 5%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: albúmina humana
Other descriptive name: HUMAN ALBUMIN SOLUTION
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 50-
Instituto Grifols S.A.Not RecruitingFemale: yes
Male: yes
Phase 4Spain
157NCT02017912May 201430 July 2018Phase 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 TherapeuticsNot recruiting18 Years75 YearsAll48Phase 2United States
158NCT02166944April 201430 September 2019Tamoxifen 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 HospitalNot recruiting20 Years80 YearsAll20Phase 1/Phase 2Taiwan
159NCT01759784March 201418 January 2016Intraventricular 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 InstituteNot recruiting18 Years70 YearsBoth0Phase 1Iran, Islamic Republic of
160NCT02039401February 201428 October 2019Safety 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.Not recruiting21 Years75 YearsAll18Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
161NCT02645461January 201418 January 2016Acetylcholine 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 SapienzaNot recruiting18 YearsN/ABoth50N/A
162NCT01884571October 201316 December 2017Immunosuppression 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 AssociationNot recruiting18 YearsN/AAll31Phase 2United States
163JPRN-UMIN0000114942013/09/022 April 2019Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' droolingamyotrophic 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 Hospital National Mie HospitalNot RecruitingNot applicableNot applicableMale and Female10Not applicableJapan
164NCT01935518September 201319 February 2015A 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 HospitalRecruiting18 Years70 YearsBoth10Phase 2China
165NCT02164253September 201316 December 2017Focal 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, LilleApoPharmaNot recruiting18 Years85 YearsAll23Phase 2France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
166NCT01771640August 201311 June 2018Intrathecal 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 InstituteNot recruiting18 Years65 YearsAll8Phase 1Iran, Islamic Republic of
167NCT01786174August 201319 October 2017Gilenya 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 InstituteNot recruiting18 YearsN/AAll30Phase 2United States
168NCT01854294August 201326 August 2019GM604 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 HospitalNot recruiting18 YearsN/AAll12Phase 2United States
169NCT01849770July 201319 October 2017Mexiletine 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 WashingtonNot recruiting18 YearsN/AAll75Phase 2United States
170NCT01906658July 201319 October 2017A 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 injectionMallinckrodtNot recruiting18 Years80 YearsAll43Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
171NCT01811355May 201316 December 2017Mexiletine 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 AssociationNot recruiting21 Years89 YearsAll23Phase 4United States
172EUCTR2011-004482-32-DE10/04/20138 August 2016Efficacy, 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 TrialAmyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: AZILECT® 1 mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagiline Mesilate
CAS Number: 161735-79-1
Other descriptive name: RASAGILINE MESILATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Universitätsklinikum UlmNot RecruitingFemale: yes
Male: yes
Phase 2Germany
173NCT01806857April 201316 December 2017Clinical 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 UniversityNot recruiting18 YearsN/AAll90Phase 2United States
174NCT02588677April 201318 December 2018Masitinib 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 ScienceNot recruiting18 YearsN/AAll394Phase 2/Phase 3Spain
175EUCTR2011-004798-99-DE27/02/201327 October 2014Safety and Efficacy of SOD1 Inhibition By Pyrimethamine in Familial (ALS)Safety and Efficacy of SOD1 Inhibition By Pyrimethamine in Familial (ALS) - Pyrimethamine In Familial ALSFamilial amyotrophic lateral sclerosis (FALS)
MedDRA version: 14.1 Level: LLT Classification code 10036704 Term: Primary lateral sclerosis System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Daraprim
Pharmaceutical Form: Tablet
INN or Proposed INN: PYRIMETHAMINE
CAS Number: 58-14-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Weill Medical College of Cornell UniversityNot RecruitingFemale: yes
Male: yes
40United States;Germany;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
176EUCTR2011-006254-85-ES08/02/201325 February 2013Clinical trial to value the safety and efficacy of administration of stem cells derived from own patient for the treatment of Amyotrophic Lateral Sclerosis (ALS).Placebo controlled, randomized and triple blind multicentric phase I/II clinical trial to evaluate the safety, feasibility and valoration of efficacy trends of intravenous administration of three doses of autologous adipose derived autologous mesenchymal stem cells (CeTMAd) in moderate/severe ALS patients.Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Células madre mesenquimales de tejido adiposo autólogo
Pharmaceutical Form: Suspension for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: Células Mesenquimales de tejido adiposo
Concentration unit: kg kilogram(s)
Concentration type: range
Concentration number: 4000000-1000000
Pharmaceutical form of the placebo: Suspension for infusion
Route of administration of the placebo: Intravenous use
FUNDACIÓN PROGRESO Y SALUDAuthorisedFemale: yes
Male: yes
Phase 1/2Spain
177EUCTR2010-024423-24-ES29/01/201330 April 2018Evaluation 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 applicablepatients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Masitinib mesylate
CAS Number: 790299-79-5
Current Sponsor code: AB1010
Other descriptive name: MASITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
ABScienceNot RecruitingFemale: yes
Male: yes
45Phase 2Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy
178NCT01759797January 201321 July 2016Intravenous 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 InstituteNot recruiting18 Years65 YearsBoth6Phase 1Iran, Islamic Republic of
179NCT01776970January 201316 December 2017Safety 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 PadovaNot recruiting18 Years80 YearsAll60Phase 2/Phase 3Italy
180NCT01835782January 201310 August 2015Determining 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 EthnomedicineNot recruiting18 Years85 YearsBoth20Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
181EUCTR2012-003349-13-BE06/12/201217 August 2015A 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 ALSAmyotrophic Lateral Sclerosis (ALS)
MedDRA version: 15.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Ozanezumab
CAS Number: 1310680-64-8
Current Sponsor code: GSK1223249
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
GlaxoSmithKline Research and Development LimitedNot RecruitingFemale: yes
Male: yes
294Phase 2Australia;Germany;Netherlands;United Kingdom;France;United States;Canada;Belgium;Italy;Japan;Korea, Republic of
182NCT01753076December 1, 201216 December 2017Study 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: PlaceboGlaxoSmithKlineNot recruiting18 Years80 YearsAll304Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;United Kingdom
183NCT01777646December 201211 June 2018Autologous 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 OrganizationNot recruiting20 Years75 YearsAll14Phase 2Israel
184NCT01825551November 201219 February 2015The 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 SciencesNot recruiting18 Years85 YearsBoth40Phase 2/Phase 3Iran, Islamic Republic of
185NCT01160263October 201225 May 2015Study 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);AGEPSNot recruiting39 Years66 YearsBoth16Phase 3France
No.TrialIDDate_
enrollement
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PhaseCountries
186NCT01709149October 201216 December 2017Study 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: RiluzoleCytokineticsNot recruiting18 YearsN/AAll711Phase 2United States;Canada;France;Germany;Ireland;Netherlands;Spain;United Kingdom
187NCT01786603September 201216 December 2017Rasagiline 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, MDNot recruiting21 Years80 YearsAll80Phase 2United States
188NCT01933321September 201213 April 2015Effect 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. GonzalezNot recruiting18 YearsN/ABoth14Phase 2/Phase 3Mexico
189EUCTR2011-006119-70-SE15/05/20123 June 2013Clinical 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 - ENVISIONAmyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Pharmaceutical Form: Film-coated tablet
CAS Number: 908244-04-2
Current Sponsor code: BIIB050 / KNS-760704
Other descriptive name: Dexpramipexole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Biogen Idec Research LimitedNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
190NCT01609283May 201216 September 2019A 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 ClinicNot recruiting18 YearsN/AAll27Phase 1United States
No.TrialIDDate_
enrollement
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size
PhaseCountries
191EUCTR2011-000362-35-CZ29/03/20124 September 2017Safety 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 ALSAmyotrophic lateral sclerosis
MedDRA version: 17.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Suspension of human autologous MSC 3P in 1,5 ml
Product Code: AMSC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human autologous mesenchymal stem cells
Current Sponsor code: AMSC
Concentration unit: million organisms/ml million organisms/millilitre
Concentration type: range
Concentration number: 7-13
Bioinova, s.r.o.Not RecruitingFemale: yes
Male: yes
30Phase 2Czech Republic
192NCT01536249March 201219 February 2015Dexpramipexole 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 BiosciencesNot recruiting18 Years55 YearsBoth14Phase 1United States
193NCT01565395March 201216 December 2017Incobotulinum 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 PharmaceuticalsNot recruiting20 Years80 YearsAll0Phase 2United States
194NCT01551940February 201224 August 2015Toxin 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 LyonNot recruiting18 YearsN/ABoth18Phase 2France
195NCT01511029January 201219 February 2015Study 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 BiosciencesNot recruiting18 Years60 YearsBoth68Phase 1United States
No.TrialIDDate_
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196NCT03828123January 201225 February 2019Autologous 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 RepublicNot recruiting18 Years65 YearsAll26Phase 1/Phase 2
197NCT01232738December 201111 June 2018Trial 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 GroupNot recruiting21 Years80 YearsAll36Phase 2United States;Canada
198NCT01492686December 201129 June 2015Phase 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 CorporationNot recruiting20 Years75 YearsBoth137Phase 3Japan
199NCT01640067December 201118 January 2016Human 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 ItalyNot recruiting20 Years75 YearsBoth18Phase 1Italy
200EUCTR2010-023161-21-FR23/11/20113 April 2017Sclérose 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-TOXSclérose Latérale Amyotrophique (SLA)
MedDRA version: 14.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BOTOX 100 UNITES ALLERGAN (PR1)
Pharmaceutical Form: Powder for solution for injection
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Other use (Noncurrent)
Hospices Civils de LyonAuthorisedFemale: yes
Male: yes
Phase 2France
No.TrialIDDate_
enrollement
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201NCT01449578November 201119 February 2015Dexpramipexole 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 BiosciencesNot recruiting18 Years55 YearsBoth63Phase 1United States
202NCT01486849November 201113 May 2019Dose 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 MGCytokineticsNot recruiting18 YearsN/AAll27Phase 2United States
203JPRN-UMIN0000064232011/10/012 April 2019The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosisamyotrophic lateral sclerosisadministration of mexiletine and riluzole
administration of riluzole only
Department of Neurology, Graduate School of Medicine, Chiba University, Japan.Not Recruiting20years-oldNot applicableMale and Female60Not selectedJapan
204EUCTR2011-001329-26-IT03/08/20113 February 2014Erythropoietin 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 - EPOSS2010Amyotrophic Lateral Sclerosis
MedDRA version: 14.0 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: EPREX*1SIR 40000UI/ML 1ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ERYTHROPOIETIN
CAS Number: 11096-26-7
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 40000-
ISTITUTO NEUROLOGICO CARLO BESTAAuthorisedFemale: yes
Male: yes
40Italy
205NCT01424163August 201119 February 2015Dexpramipexole 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 IdecNot recruiting18 Years60 YearsBoth56Phase 1United Kingdom
No.TrialIDDate_
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206NCT01424176July 201119 February 2015Dexpramipexole 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 BiosciencesNot recruiting18 Years75 YearsBoth36Phase 1United States
207NCT01051882June 201121 January 2019Autologous 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 OrganizationNot recruiting20 Years75 YearsAll12Phase 1/Phase 2Israel
208NCT01378676June 201113 May 2019A 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)CytokineticsNot recruiting18 YearsN/AAll49Phase 2United States
209EUCTR2010-022818-19-GB22/03/20114 February 2013Clinical 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. - EMPOWERamyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dexpramipexole Dichydrochloride
CAS Number: 908244-04-2
Current Sponsor code: BIIB050 / KNS-760704
Other descriptive name: Dexpramipexole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Biogen Idec LimitedNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
210EUCTR2010-021179-10-DE15/03/201122 October 2012An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.Amyotrophic Lateral Sclerosis.
MedDRA version: 12.1 Level: LLT Classification code 10052889 Term: ALS
Product Name: olesoxime
Product Code: TRO19622
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: olesoxime
CAS Number: 2203-87-0
Current Sponsor code: TRO19622
Other descriptive name: 4-cholesten-3-one, oxime
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 165-
TROPHOS SANot RecruitingFemale: yes
Male: yes
Spain;Germany;United Kingdom
No.TrialIDDate_
enrollement
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211NCT00876772March 201119 February 2015Olanzapine 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, GermanyRecruiting18 Years80 YearsBoth40Phase 2/Phase 3Germany
212NCT01257581March 201119 October 2017Safety 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 UniversityNot recruiting18 YearsN/AAll60Phase 2United States
213NCT01277315February 201119 February 2015Safety 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
214NCT01281631February 201119 February 2015A 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.Not recruiting21 Years80 YearsBoth136Phase 2United States
215NCT01363401February 201116 December 2017Safety 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.Not recruiting25 Years75 YearsAll72Phase 1/Phase 2Korea, Republic of
No.TrialIDDate_
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216NCT02880033February 201115 July 2019Oxidative 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, LilleNot recruiting18 Years80 YearsAll90N/AFrance
217EUCTR2010-022808-40-IT13/01/201127 January 2014A 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 - NDamyotrophic lateral sclerosis
MedDRA version: 9.1 Level: PT Classification code 10002026
Trade Name: sativex
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: sativex
Concentration unit: µl microlitre(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Buccal use
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABORAuthorisedFemale: yes
Male: yes
Italy
218NCT01259050October 201019 February 2015Safety 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, LTDNot recruiting18 Years85 YearsBoth10Phase 1/Phase 2United States
219NCT01285583October 20105 December 2016Safety 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 RocheNot recruitingN/AN/ABoth271Phase 2/Phase 3Belgium;France;Germany;Spain;United Kingdom
220NCT03085706October 201019 February 2018Transplantation 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 UniversityNot recruiting31 Years75 YearsAll14N/AChina
No.TrialIDDate_
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221EUCTR2010-020257-13-IT30/07/201019 March 2012A 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 ALSPATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1 Level: SOC Classification code 10029205
Trade Name: MYONAL*30CPR RIV 100MG
Pharmaceutical Form: Tablet
INN or Proposed INN: EPERISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: LIORESAL*50CPR 10MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Baclofen
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
AZIENDA OSPEDALIERO-UNIVERSITARIANot RecruitingFemale: yes
Male: yes
Phase 2Italy
222NCT01091142July 201019 February 2015Single-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.Not recruiting21 Years75 YearsBoth56Phase 1United States
223EUCTR2008-003982-21-FR10/06/201016 November 2015Etude 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 - DOSERALSPatients présentant une SLA et volontaires sains
MedDRA version: 8.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: DaTSCAN
Product Name: Datscan
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ioflupane 123I
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: equal
Concentration number: 74-
Product Name: [I-123] ADAM
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [I-123] ADAM
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: equal
Concentration number: 30 +/- 10-
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)Not RecruitingFemale: yes
Male: yes
France
224NCT01142856June 201019 February 2015Mesenchymal 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 ClinicNot recruiting18 YearsN/ABoth1Phase 1United States
225EUCTR2009-016066-91-IT10/03/201019 March 2012SAFETY 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 - NDALS
MedDRA version: 9.1 Level: SOC Classification code 10029205
Trade Name: EPREX*1SIR 40000UI/ML 1ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Erythropoietin
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 40000-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
ISTITUTO NEUROLOGICO CARLO BESTAAuthorisedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
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226NCT01082653March 201019 February 2015Safety/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 TherapyNot recruiting18 Years80 YearsBoth6Phase 1United States
227NCT01089010March 201020 May 2019A 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-2017357CytokineticsNot recruiting18 YearsN/AAll67Phase 2United States
228NCT01041222January 201019 February 2015Safety, 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 AssociationNot recruiting18 YearsN/ABoth33Phase 1United States
229NCT02193893January 201019 February 2015Biological 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 SzczecinRecruiting18 Years65 YearsBoth50Phase 1Poland
230NCT01016522November 200913 April 2015Safety 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 UniversityNot recruiting18 YearsN/ABoth1Phase 3United States
No.TrialIDDate_
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231NCT01083667November 200916 December 2017SOD1 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 AssociationNot recruiting18 YearsN/AAll32Phase 1/Phase 2United States;Germany;Italy;Sweden
232NCT00983983October 200919 October 2017High 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 AssociationNot recruiting18 YearsN/AAll28Phase 2United States
233NCT00982150September 200919 February 2015Extension 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 IndustriesNot recruiting18 Years80 YearsBoth446Phase 2United States;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain
234JPRN-UMIN0000022762009/08/012 April 2019Developmental research of communication devices based on the brain machine interface using electroencephalogramsamyotrophic lateral sclerosisLet the patients use the communication devices to select characters on a computer monitor as they intend by recording EEG.Osaka UniversityNot Recruiting20years-oldNot applicableMale and Female10Not applicableJapan
235NCT00931944July 20098 January 2018Open-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 BiosciencesNot recruiting21 Years80 YearsAll74Phase 2United States
No.TrialIDDate_
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236NCT00965497July 200919 October 2017Escitalopram (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 CarolinaNot recruiting18 Years70 YearsAll13Phase 3United States
237EUCTR2008-007320-25-DE24/06/20093 April 2012Phase 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 riluzoleALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: olesoxime
CAS Number: 2203-87-0
Current Sponsor code: TRO19622
Other descriptive name: 4-cholesten-3-one, oxime
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 165-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
TROPHOS SANot RecruitingFemale: yes
Male: yes
470Phase 2/3United Kingdom;Germany;Belgium;France;Spain
238EUCTR2008-006722-34-IT23/06/200919 March 2012Multicentric 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 LithiumAmyotrophic Lateral Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: CARBOLITHIUM
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
ISTITUTO SUPERIORE DI SANITA`Not RecruitingFemale: yes
Male: yes
Italy
239EUCTR2008-006224-61-ES12/06/200919 March 2012Ensayo 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 AmiotróficaEsclerosis Lateral Amiotrófica
MedDRA version: 9 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: PLENUR
Pharmaceutical Form: Tablet
INN or Proposed INN: LITIO CARBONATO
CAS Number: 554-13-2
Other descriptive name: LITHIUM CARBONATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Institut de Recerca de l'Hospital de la Santa Creu i Sant PauNot RecruitingFemale: yes
Male: yes
Spain
240NCT00925847June 200919 February 2015Effect 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 ParisNot recruiting18 YearsN/ABoth23Phase 2France
No.TrialIDDate_
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241NCT01384162June 20098 February 2016An 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 ResearchNot recruiting18 Years75 YearsBoth15Phase 1/Phase 2Belgium
242EUCTR2008-005106-38-ES14/05/200919 March 2012ENSAYO 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) - LIELAEsclerosis Lateral Amiotrofica
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: PLENUR
Pharmaceutical Form: Tablet
INN or Proposed INN: LITIO CARBONATO
CAS Number: 554-13-2
Other descriptive name: LITHIUM CARBONATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Lucia Galan Hospital Clinico San CarlosNot RecruitingFemale: yes
Male: yes
280Spain
243NCT00875446May 13, 200916 December 2017First 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: GSK1223249GlaxoSmithKlineNot recruiting18 Years80 YearsAll76Phase 1United States;France;Italy;United Kingdom
244NCT00868166April 30, 200911 March 2019Safety 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 CommissionNot recruiting18 Years80 YearsAll512Phase 3Belgium;France;Germany;Spain;United Kingdom;Netherlands
245NCT00886977April 200919 February 2015Efficacy 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 ClinicNot recruiting25 Years65 YearsBoth25Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
246EUCTR2009-010060-41-IT24/02/200919 March 2012Evaluation 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. - NDAmyotrophic Lateral Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: LITIO CARBONATO
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: RILUTEK
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riluzole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
AZIENDA OSPEDALIERA PISANANot RecruitingFemale: yes
Male: yes
Italy
247JPRN-UMIN0000085272009/01/012 April 2019Study of efficacy and safety of NDDPX08 in ALS patientsAmyotrophic 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.
FeGALSNot Recruiting20years-old75years-oldMale and Female50Not selectedJapan
248NCT00706147January 200921 January 2019Phase 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 HospitalNot recruiting18 YearsN/AAll38Phase 2/Phase 3United States
249NCT00818389January 200919 October 2017Study 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 KentuckyNot recruiting18 YearsN/AAll84Phase 2/Phase 3United States;Canada
250NCT00800501December 200819 February 2015A 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 ResearchNot recruiting18 Years75 YearsBoth18Phase 1/Phase 2Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
251NCT01984814December 20085 November 2018Stem 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 InstituteNot recruiting26 Years76 YearsAll0Phase 2India
252NCT02242071December 20085 November 2018Cell 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 InstituteNot recruiting18 Years80 YearsAll0Phase 1India
253EUCTR2007-003775-39-DE29/10/20083 June 2013Randomised, 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 losspatients with amyotrophic lateral sclerosisTrade Name: Zyprexa
Pharmaceutical Form: Tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Charité – Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
Germany
254EUCTR2008-002062-62-NL14/10/200819 March 2012A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1 Level: PT Classification code 10052653 Term: Amyotrophic lateral sclerosis gene carrier
Product Name: talampanel
Product Code: TV-7110
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available yet
CAS Number: 161832-65-1
Current Sponsor code: TV-7110
Other descriptive name: talampanel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5 and 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: talampanel
Product Code: TV-7110
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available yet
CAS Number: 161832-65-1
Current Sponsor code: TV-7110
Other descriptive name: talampanel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5 and 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Teva Pharmaceutical Industries, LtdNot RecruitingFemale: yes
Male: yes
540Hungary;Germany;Netherlands;Belgium;France;Spain;Italy
255EUCTR2008-003707-32-FR09/10/200819 March 2012Etude 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 - LISLAPatient atteint de sclérose latérale amyotrophique.
MedDRA version: 8.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: Téralithe LP
Product Name: Téralithe LP
Pharmaceutical Form: Tablet
INN or Proposed INN: Carbonate de lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)AuthorisedFemale: yes
Male: yes
France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
256EUCTR2008-002110-22-NL16/09/200819 March 2012A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALSA randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALSAmyotrophic lateral sclerosis (ALS) is a disease characterised by progressive degeneration of motor neurons in brain and spinal cord leading to muscle weakness. ALS can occur at anytime in adulthood. Muscle weakness gradually progresses. Approximately 50% of patients die within 3 years after onset of symptoms, usually as the result of respiratory failure. To date, only one drug, i.e. riluzole, has proven to extend survival in patients with ALS, but only by approximately 3 to 6 months.
MedDRA version: 9.1 Level: LLT Classification code 10052889 Term: ALS
Trade Name: Lithiumcarbonaat 400 PCH tabletten
Product Name: Lithiumcarbonaat
Pharmaceutical Form: Tablet
CAS Number: 554132
Other descriptive name: LITHIUM CARBONATE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 400-400
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Prof. dr L.H. van den Berg, UMC-UtrechtNot RecruitingFemale: yes
Male: yes
Netherlands
257NCT00696332September 200819 February 2015Talampanel 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 IndustriesNot recruiting18 Years80 YearsBoth559Phase 2United States;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain
258NCT00748501September 200819 February 2015Clinical 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 BiosciencesNot recruiting18 Years85 YearsBoth45Phase 2United States
259NCT00694941June 200819 February 2015A 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. LtdNot recruiting18 YearsN/ABoth15Phase 2Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
260NCT00919555June 200819 February 2015Combination 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, LTDNot recruiting18 Years85 YearsBoth28Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
261EUCTR2007-004723-37-DE16/05/200819 March 2012A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Arundic Acid
CAS Number: 185517-21-9
Current Sponsor code: ONO-2506PO
Other descriptive name: (2R)-2-Propyloctanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
ONO Pharmaceutical Co., Ltd.Not RecruitingFemale: yes
Male: yes
273Phase 2United Kingdom;Germany;Belgium;France
262NCT00790582May 200819 February 2015A 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 AssociationNot recruiting21 Years80 YearsBoth100Phase 2United States
263EUCTR2006-005410-13-DE22/04/20084 February 2013EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE).EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE).Male or female adult patients with amyotrophic lateral sclerosis (ALS) accoring to the El Escorial Criteria for the diognosis of ALS and treated for at least 3 month with 100 mg riluzole (standard therapy).
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: Actos 15 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Actos 30 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Actos 45 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
University Hospital of UlmNot RecruitingFemale: yes
Male: yes
Germany
264EUCTR2008-001094-15-IT10/03/200819 March 2012SINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - NDSINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - NDALS patient according with the El-Escorial criteria
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: CARBOLITHIUM*100CPS 150MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINOAuthorisedFemale: yes
Male: yes
Italy
265NCT00647296March 20088 January 2018Safety 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 BiosciencesNot recruiting21 Years80 YearsAll102Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
266EUCTR2007-001592-10-IT15/02/200819 March 2012A randomized, double-blind 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 sclerosis. - TUDCA-ALSA randomized, double-blind 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 sclerosis. - TUDCA-ALSAMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Product Name: Tauroursodeoxycholic acid
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: Tauroursodeoxycholic acid
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Prolonged-release capsule, hard
Route of administration of the placebo: Oral use
ISTITUTO NEUROLOGICO CARLO BESTAAuthorisedFemale: yes
Male: yes
Italy
267NCT00445172February 200816 December 2017A 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.Not recruiting20 YearsN/AAll135Phase 2/Phase 3Japan
268EUCTR2007-002117-39-ES31/01/200819 March 2012MEMANTINA (Ebixa X) PARA LA DISCAPACIDAD FUNCIONAL EN LA ESCLEROSIS LATERAL AMIOTRÓFICA MEMANTINE (Ebixa R) FOR FUNCTIONAL DISABILITY IN AMYOTROPHIC LATERAL SCLEROSIS . - MEDALSMEMANTINA (Ebixa X) PARA LA DISCAPACIDAD FUNCIONAL EN LA ESCLEROSIS LATERAL AMIOTRÓFICA MEMANTINE (Ebixa R) FOR FUNCTIONAL DISABILITY IN AMYOTROPHIC LATERAL SCLEROSIS . - MEDALSEsclerosis Lateral Amiotrofica Amyotrophic lateral Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: EBIXA
Pharmaceutical Form: Tablet
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
CAS Number: 41100-52-1
Current Sponsor code: EU/1/02/219/007-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 99%-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Jorge Matias-Guiu GuiaAuthorisedFemale: yes
Male: yes
140Spain
269NCT00561366January 200819 February 2015A 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: ArimoclomolCytRxNot recruiting18 YearsN/ABoth0Phase 2United States;Canada
270NCT00753571January 200819 February 2015Cistanche 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 UniversityRecruiting18 Years65 YearsBoth40Phase 2China
No.TrialIDDate_
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Last_Refreshed_
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271NCT00573443December 200716 December 2017Safety 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 ResearchNot recruiting18 Years80 YearsAll326Phase 3United States;Argentina;Brazil
272EUCTR2007-004165-17-IT25/09/200719 March 2012Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - NDEfficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - NDAmyotrophic lateral sclerosis (ALS)
MedDRA version: 6.1 Level: PT Classification code 10002026
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Ceftriaxone
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
AZIENDA OSPEDALIERA PISANANot RecruitingFemale: yes
Male: yes
Italy
273NCT00600873August 200719 February 2015R(+)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.Not recruiting30 Years80 YearsBoth10Phase 1/Phase 2United States
274EUCTR2007-002379-16-IT29/05/200717 February 2014MULTICENTER 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 ALSPatients affected by amyotrophic lateral sclerosis (ALS)
MedDRA version: 6.1 Level: PT Classification code 10002026
Trade Name: CARBOLITHIUM
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
I.N.M. NEUROMED (I.R.C.C.S.) S.R.L. GIA' SANATRIXNot RecruitingFemale: yes
Male: yes
Italy
275NCT00444613April 200719 February 2015A 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.Not recruiting20 YearsN/ABoth373Phase 2/Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
276NCT00409721March 200719 February 2015The 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 AssociationNot recruiting18 Years80 YearsBoth42Phase 2Canada
277NCT00635960March 200719 February 2015Growth 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 FarmacoNot recruiting40 Years85 YearsBoth40Phase 2Italy
278EUCTR2006-002660-26-GB08/01/200719 March 2012A 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 RANDOMISATIONAmyotrophic Lateral Sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Arundic Acid
CAS Number: 185517-21-9
Current Sponsor code: ONO-2506
Other descriptive name: (2R)-2-Propyloctanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
ONO Pharmaceutical Co.,LtdNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
279NCT00424463January 200719 February 2015Expanded 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 CorporationNot recruiting20 YearsN/ABoth181Phase 3Japan
280NCT00372879December 200611 April 2016Clinical 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 InstituteNot recruiting18 YearsN/ABoth32Phase 3Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT00397423December 200619 February 2015G-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 UniversityNot recruiting18 Years65 YearsBoth40Phase 2China
282NCT00415519December 200619 February 2015Efficacy 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 CorporationNot recruiting20 Years75 YearsBoth25Phase 3Japan
283EUCTR2006-002660-26-BE13/11/200619 March 2012A 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 RANDOMISATIONAmyotrophic Lateral Sclerosis
MedDRA version: 8.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Arundic Acid
CAS Number: 185517-21-9
Current Sponsor code: ONO-2506
Other descriptive name: (2R)-2-Propyloctanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
ONO Pharmaceutical Co.,LtdNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
284NCT00403104November 200619 February 2015Placebo 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. LtdNot recruiting18 Years74 YearsBoth420Phase 2Austria;Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
285EUCTR2006-001688-49-GB14/08/200619 March 2012A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.Early stage of amyotrophic lateral sclerosis (ALS)
MedDRA version: 8.1 Level: PT Classification code 10002026
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
Pharmaceutical Form: Solution for injection
CAS Number: 147245-92-9
Current Sponsor code: 40 mg GA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
TEVA Pharmaceutical Industries. Ltd.AuthorisedFemale: yes
Male: yes
366Germany;United Kingdom;Belgium;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
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PhaseCountries
286NCT00326625July 31, 200626 February 2018Clinical 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.Not recruiting18 Years70 YearsAll366Phase 2Belgium;France;Germany;Israel;Italy;United Kingdom
287NCT00349622July 200619 October 2017Clinical 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)Not recruiting18 YearsN/AAll513Phase 3United States;Canada;Puerto Rico
288NCT00355576July 200619 February 2015Combination 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;PfizerNot recruiting21 Years85 YearsBoth86Phase 2United States
289NCT00324454May 200619 February 2015Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron DiseaseA Pilot Trial of Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron DiseaseMotor Neuron Disease;Amyotrophic Lateral Sclerosis;Primary Lateral Sclerosis;Progressive Muscular AtrophyBiological: LevetiracetamDuke UniversityUCB PharmaNot recruiting18 YearsN/ABoth20Phase 2United States
290NCT00330681May 200616 December 2017Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.Amyotrophic Lateral Sclerosis (ALS)Drug: MCI-186;Drug: Placebo of MCI-186Mitsubishi Tanabe Pharma CorporationNot recruiting20 Years75 YearsAll206Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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gender
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size
PhaseCountries
291EUCTR2005-005152-40-IT19/04/200619 March 2012MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALSMULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALSALS
MedDRA version: 6.1 Level: PT Classification code 10002026
Product Name: ALPHA-LIPOIC ACID
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tioctic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINOAuthorisedFemale: yes
Male: yes
84Italy
292NCT00231140December 200519 February 2015Pilot-Study of Thalidomide in Amyotrophic Lateral Sclerosis (ALS)Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Thalidomide (drug)Charite University, Berlin, GermanyNot recruiting25 Years80 YearsBoth40Phase 2Germany
293NCT00244244October 200519 February 2015A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALSA Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: arimoclomolCytRxNot recruiting18 YearsN/ABoth80Phase 2United States
294NCT00596115October 200519 February 2015Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/DayOpen Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per DayAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.University of Pittsburgh;University of NebraskaNot recruiting30 Years80 YearsBothN/A
295EUCTR2005-003248-75-IT31/08/200519 March 2012PILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSISPILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSISSLOWING OF ALS PROGRESSION
MedDRA version: 6.1 Level: PT Classification code 10002026
Trade Name: MYELOSTIM 34*1FL 263MCG+1SIR
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Lenograstim
CAS Number: 135968-09-1
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINOAuthorisedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
296EUCTR2005-005873-31-IT01/08/200519 March 2012A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - NDA randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - NDAmiotrophic Lateral Sclerosis
MedDRA version: 6.1 Level: PT Classification code 10002026
Trade Name: EPREX IV SC 1FL 1ML 40000 UI
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Erythropoietin
CAS Number: 113427-24-0
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
ISTITUTO NEUROLOGICO CARLO BESTANot RecruitingFemale: yes
Male: yes
20Italy
297NCT00140218August 200519 February 2015R(+) Pramipexole in Early Amyotrophic Lateral SclerosisFutility Study of R(+) Pramipexole in Early Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.University of PittsburghNot recruiting21 Years85 YearsBoth30Phase 1/Phase 2United States
298NCT00353665July 200519 February 2015Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)Phase 2-3 - Memantine for Disability in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Memantine (Ebixa);Drug: riluzole;Drug: PlaceboUniversity of LisbonH. Lundbeck A/SNot recruiting20 Years75 YearsBoth63Phase 2/Phase 3Portugal
299NCT01020331June 200519 February 2015Memantine Therapy in Amyotrophic Lateral SclerosisPhase IIA Open Label Trial of Memantine in Combination With Riluzole (Customary Care) for the Treatment of ALSAmyotrophic Lateral SclerosisDrug: MemantinePhoenix Neurological Associates, LTDForest LaboratoriesNot recruiting18 Years85 YearsBoth20Phase 2United States
300EUCTR2004-004158-23-IT15/04/200519 March 2012DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - NDDOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - NDAmyotrophic lateral sclerosis therapy
MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Trade Name: ZIBREN*20BUST 500MG
Pharmaceutical Form: Oral powder
INN or Proposed INN: Acetylcarnitine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
IST. DI RICERCHE FARMACOLOG. M. NEGRINot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
301NCT00107770April 200519 February 2015Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: sodium phenylbutyrateDepartment of Veterans AffairsMuscular Dystrophy AssociationNot recruiting18 YearsN/ABoth40Phase 1/Phase 2United States
302NCT00136110April 200519 February 2015Trial of Sodium Valproate in Amyotrophic Lateral SclerosisA Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALSAmyotrophic Lateral SclerosisDrug: Sodium ValproateUMC UtrechtPrincess Beatrix Fund, The NetherlandsNot recruiting18 Years85 YearsBoth165Phase 3Netherlands
303NCT00243932April 200519 October 2017Clinical Trial of High Dose CoQ10 in ALSClinical Trial of High Dose CoQ10 in ALSAmyotrophic Lateral Sclerosis;Lou Gehrig's DiseaseDrug: coenzyme Q10;Drug: PlaceboColumbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting21 Years85 YearsAll185Phase 2United States
304NCT00812851April 200519 February 2015Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Cramps;Amyotrophic Lateral SclerosisDrug: DronabinolCantonal Hospital of St. GallenALS AssociationNot recruiting18 YearsN/ABoth24N/ASwitzerland
305NCT00140452February 200519 February 2015Phase II Study Using Thalidomide for the Treatment of ALSPhase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;ALSDrug: ThalidomideDartmouth-Hitchcock Medical CenterCelgene CorporationNot recruiting18 Years80 YearsBoth24Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
306EUCTR2004-002855-15-DE29/12/200418 April 2012A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis.A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis.Amyotrophic Lateral SclerosisProduct Code: TCH346
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not established
CAS Number: 200189-97-5
Current Sponsor code: TCH346
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0, 2.5, 7.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
480United Kingdom;Germany;Italy
307EUCTR2004-002390-23-DE24/11/200419 March 2012Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjectsEvaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjectsamyotrophic lateral sclerosis
Classification code 10002026
Trade Name: RILUTEK
Product Name: RILUTEK 50 mg, film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riluzole
Current Sponsor code: XRP4274
Concentration unit: mg milligram(s)
Concentration number: 50-
Aventis Pharma Ltd.Not RecruitingFemale:
Male: yes
Germany
308NCT00230074November 200419 February 2015A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)Amyotrophic Lateral SclerosisDrug: TCH346NovartisNot recruiting21 Years80 YearsBoth350Phase 2United States
309EUCTR2004-002912-27-ES04/10/200419 March 2012Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD).Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD).Amyotrophic lateral sclerosis
MedDRA version: 7.0 Level: LL 1 Classification code 10002026
Product Name: ONO-2506PO
Product Code: ONO-2506PO
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: (R)-(-)-2-Propyloctaroic acid
Current Sponsor code: ONO-2506PO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
ONO PHARMA UK LTDAuthorisedFemale: yes
Male: yes
500Spain
310NCT00072709September 200319 February 2015Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: TCH346Novartis PharmaceuticalsNot recruiting21 Years80 YearsBoth551Phase 2United States;Belgium;Canada;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
No.TrialIDDate_
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311NCT00125203July 200319 February 2015Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;SialorrheaDrug: Botulinum toxin type B (Myobloc);Procedure: Injection of salivary glandsThe University of Texas Health Science Center at San AntonioALS Association;University of Kansas;Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical SystemNot recruiting21 Years85 YearsBoth20Phase 2/Phase 3United States
312NCT00035815June 200319 October 2017Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) TrialInsulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Insulin like growth factor, type 1;Drug: PlaceboMayo ClinicNational Institute of Neurological Disorders and Stroke (NINDS);ALS Association;CephalonNot recruiting18 Years80 YearsAll330Phase 3United States;Puerto Rico
313NCT00069186June 200319 February 2015Study of Creatine Monohydrate in Patients With Amyotrophic Lateral SclerosisA Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: Creatine MonohydrateThe Avicena GroupNot recruiting21 Years80 YearsBoth107Phase 3United States
314NCT00047723January 200319 February 2015Minocycline to Treat Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: minocyclineNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting21 Years85 YearsBoth400Phase 3United States
315NCT00070993December 200219 February 2015Creatine for the Treatment of Amyotrophic Lateral SclerosisClinical Trial of Creatine in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: creatine monohydrateNational Center for Complementary and Integrative Health (NCCIH)Office of Dietary Supplements (ODS)Not recruiting21 Years80 YearsBoth110Phase 2United States
No.TrialIDDate_
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size
PhaseCountries
316NCT00036413January 200219 February 2015A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral SclerosisA 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.Amyotrophic Lateral SclerosisDrug: TCH346Novartis PharmaceuticalsNot recruiting40 Years75 YearsBoth44Phase 2United States
317NCT00021697January 20018 August 2016Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALSA Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: AVP-923Avanir PharmaceuticalsNot recruiting18 Years80 YearsBoth100Phase 3United States
318NCT00214110January 200112 October 2015Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS]Amyotrophic Lateral Sclerosis (ALS)Drug: TamoxifenUniversity of Wisconsin, MadisonNot recruiting18 Years90 YearsBoth100Phase 2United States
319NCT00542412January 200119 February 2015CARE Canadian ALS Riluzole EvaluationCare (Canadian ALS Riluzole Evaluation) Multicentre Phase IV Comparative Study of the Effects of Riluzole 50mg Bid on the Survival of ALS Subjects Compared to Historical ControlsAmyotrophic Lateral SclerosisDrug: RiluzoleSanofiNot recruiting18 Years75 YearsBoth414Phase 4Canada
320NCT00005674May 200019 February 2015Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS]Amyotrophic Lateral SclerosisDrug: CreatineNational Center for Research Resources (NCRR)Muscular Dystrophy AssociationNot recruiting18 Years80 YearsBothPhase 2United States
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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size
PhaseCountries
321NCT00005766May 200019 February 2015Clinical Trial of Creatine in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: CreatinineNational Center for Research Resources (NCRR)Not recruiting18 Years80 YearsBothPhase 2United States
322NCT00004771October 199219 February 2015Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron DiseaseSpinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular AtrophyDrug: leuprolide;Drug: testosteroneNational Center for Research Resources (NCRR)Ohio State UniversityNot recruiting18 YearsN/AMale40Phase 2

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