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


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225

  
77 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2019-001862-13-PT
(EUCTR)
18/02/202221/05/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Greece;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
2EUCTR2021-003875-32-IT
(EUCTR)
15/02/202229/12/2021Clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosisA double-blind, placebo-controlled, exploratory randomised clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosis (Study TRIALS) - TRIALS Amyotrophic lateral sclerosis (bulbar-onset)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Icerguastat
Product Code: [IFB-088]
InFlectis BioScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;Italy
3EUCTR2019-001862-13-GR
(EUCTR)
03/02/202226/11/2021Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - Amyotrophic Lateral Sclerosis (ALS) patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Greece;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
4EUCTR2019-001862-13-DK
(EUCTR)
21/09/202130/06/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Sweden
5EUCTR2021-001989-38-ES
(EUCTR)
08/07/202114/06/2021COMPARISON OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE IMPROVEMENT OF PATIENTS WITH ELA WHO ARE BEING TREATED WITH RILUZOLEIMPACT OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE CLINICAL IMPROVEMENT OF PATIENTS WITH ALS TREATED WITH RILUZOLE - IMCRELA Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Dutasterida
Product Name: Dutasterida
INN or Proposed INN: DUTASTERIDE
Other descriptive name: DUTASTERIDE
Facultad de medicina y ciencias de la salud de la Universidad Católica de ValenciaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Spain
6NCT04745299
(ClinicalTrials.gov)
March 23, 202127/1/2021Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALSA Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lenzumestrocel(Neuronata-R® Inj.) in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Lenzumestrocel;Drug: Riluzole;Drug: Placebo ComparatorCorestem, Inc.NULLRecruiting25 Years75 YearsAll115Phase 3Korea, Republic of
7ChiCTR2100044085
2021-03-012021-03-09A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS).A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS). Amyotrophic lateral sclerosisexperimental group:Huoling Shengji Keli granules 1 bag + riluzole tablets simulant 1 tablet each time, Bid, oral;control group:Huoling Shengji Keli granules simulant 1 bag + riluzole tablets 1 tablet each time, Bid, oral;Peking University Third HospitalNULLRecruiting4570Bothexperimental group:72;control group:72;Phase 2China
8EUCTR2019-001862-13-IT
(EUCTR)
03/02/202106/11/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - non applicable Patients suffering from Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Masitinib mesilate
Product Code: [AB1010]
INN or Proposed INN: Masitinib mesilate
Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003
Product Name: Masitinib mesilate
Product Code: [AB1010]
INN or Proposed INN: Masitinib mesilate
Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003
AB SCIENCENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
9EUCTR2019-001862-13-NO
(EUCTR)
03/02/202120/11/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3Portugal;United States;Slovenia;Spain;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
10ChiCTR2000028960
2021-01-012020-01-09Exploratory study of low-intensity ultrasound in the disease progression of amyotrophic lateral sclerosisExploratory study of low-intensity ultrasound in the disease progression of amyotrophic lateral sclerosis Amyotrophic lateral sclerosisexperimental group:wearable low-intensity ultrasound and Riluzole;control group:ineffective ultrasound and Riluzole;University Affiliated Sixth People's HospitalNULLPending1870Bothexperimental group:20;control group:20;China
11EUCTR2019-001862-13-PL
(EUCTR)
01/12/202009/07/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
12EUCTR2019-001862-13-SE
(EUCTR)
14/10/202023/03/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3Portugal;United States;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
13NCT03127267
(ClinicalTrials.gov)
October 1, 202013/4/2017Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS PatientsA Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Masitinib (6.0);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (4.5)AB ScienceNULLRecruiting18 Years81 YearsAll495Phase 3United States;Germany;Canada
14ChiCTR2000035988
2020-10-012020-08-21Exploratory study of wearable low-intensity ultrasound in the disease progression of Amyotrophic lateral sclerosisExploratory study of wearable low-intensity ultrasound in the disease progression of Amyotrophic lateral sclerosis Amyotrophic lateral sclerosisexperimental group:wearable low-intenstiy ultrasound + riluzole;control group:invalid ultrasound + riluzole;Shanghai Sixth People's HospitalNULLPending1870Bothexperimental group:25;control group:25;China
15EUCTR2019-001862-13-ES
(EUCTR)
15/09/202012/06/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
16NCT04950933
(ClinicalTrials.gov)
June 1, 202027/6/2021The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji GranulesA Multi-center, Randomized, Double-blind, Positives Parallel Controlled, Phase ? Clinical Trial to Evaluate the Efficacy and Safety of Huollingshengji Granules in the Treatment of Amyotrophic Lateral Sclerosis (Spleen qi Deficiency, Kidney Yang Deficiency Syndrome)Amyotrophic Lateral SclerosisDrug: Huolingshengji Granules;Drug: Riluzole tabletPeking University Third HospitalThe Second Hospital of Hebei Medical UniversityRecruiting45 Years70 YearsAll144Phase 2/Phase 3China
17NCT04326283
(ClinicalTrials.gov)
April 2, 202024/3/2020Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Trametinib (0.5 mg);Drug: Trametinib (1 mg);Drug: Trametinib (2 mg);Drug: Riluzole (100 mg)GENUV Inc.NULLRecruiting19 Years75 YearsAll30Phase 1/Phase 2Korea, Republic of
18EUCTR2019-001862-13-SI
(EUCTR)
12/03/202019/02/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
19EUCTR2018-002722-22-DE
(EUCTR)
03/06/201905/02/2019Safety and efficacy of a treatment with tauroursodeoxycholic acid (TUDCA) on top of riluzole in patients affected by amyotrophic lateral sclerosis (ALS)Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TUDCABIL
INN or Proposed INN: tauroursodeoxycholic acid
Other descriptive name: TAUROURSODEOXYCHOLIC ACID
Humanitas Mirasole SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3Belgium;Netherlands;Germany;Italy;United Kingdom
20NCT03537807
(ClinicalTrials.gov)
June 20189/5/2018Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;ALS;Lou Gehrig Disease;Lou Gehrig's Disease;Lou-Gehrigs Disease;Motor Neuron Disease, Amyotrophic Lateral SclerosisDrug: RiluzoleBiohaven Pharmaceuticals, Inc.NULLNo longer available18 YearsN/AAllNULL
21NCT03679975
(ClinicalTrials.gov)
April 4, 201819/9/2018Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Riluzole Oral Soluble film (ROSF) 50 mgAquestive TherapeuticsinVentiv Health Clinical;CovanceTerminated18 Years80 YearsAll9Phase 2United States
22NCT03457753
(ClinicalTrials.gov)
March 1, 201826/2/2018Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral SclerosisA Multi-Center, Open Label Study to Assess the Safety and Tolerability of Riluzole Oral Soluble Film in Subjects With Amyotrophic Lateral Sclerosis Over 12 Weeks of Twice Daily Treatment.ALSDrug: Riluzole Oral Soluble FilmAquestive TherapeuticsInventiv Health;CovanceWithdrawn18 Years80 YearsAll0Phase 2United States
23NCT03039673
(ClinicalTrials.gov)
June 19, 201731/1/2017MIROCALS: Modifying Immune Response and OutComes in ALSEfficacy and Safety of Low-dose IL-2 (Ld-IL-2) as a Treg Enhancer for Controlling Neuro-inflammation in Newly Diagnosed Amyotrophic Lateral Sclerosis (ALS) Patients: A Randomized, Double-blind, Placebo- Controlled, Phase-II Proof of Concept/ Proof of Mechanism Clinical TrialAmyotrophic Lateral SclerosisDrug: Riluzole;Drug: IL-2;Drug: 5% glucose water solutionCentre Hospitalier Universitaire de NimesNULLCompleted18 Years75 YearsAll304Phase 2France;United Kingdom
24NCT03272802
(ClinicalTrials.gov)
March 16, 20172/9/2017Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian PopulationNeuromuscular DiseasesDrug: Edaravone;Drug: RiluzoleIsfahan University of Medical SciencesNULLActive, not recruiting18 Years75 YearsAll20Phase 2/Phase 3Iran, Islamic Republic of
25NCT04454840
(ClinicalTrials.gov)
May 1, 201629/6/2020Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral SclerosisA Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Plasma from healthy young people treatment + Riluzole;Drug: RiluzolePeking University Third HospitalNULLCompletedN/AN/AAll20Early Phase 1China
26EUCTR2014-005367-32-IT
(EUCTR)
29/02/201617/03/2017Clinical study on the efficacy and tolerabilty of Guabenz in Amiotropic Lateral SclerosisPROTEIN MISFOLDING, AMYOTROPHIC LATERAL SCLEROSIS AND GUANABENZ: A PHASE II RCT WITH FUTILITY DESIGN - PROMISE Amiotrophic Lateral Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GUANABENZ ACETATO
Product Code: GUANA2015
INN or Proposed INN: GUANABENZ
Other descriptive name: GUANABENZ
Product Name: RILUZOLO
INN or Proposed INN: RILUZOLO
Other descriptive name: RILUZOLO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Phase 2Italy
27EUCTR2015-001431-20-NL
(EUCTR)
17/08/201521/04/2015Trial to look at the nerve conductance in patients with ALS, with and without Riluzole or Retigabine.A randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS. - Peripheral motor nerve excitability study in patients with ALS Amytrophic Lateral Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rilutek 50 mg film-coated tablets
Product Name: Rilutek
INN or Proposed INN: RILUZOLE
Trade Name: Trobalt
Product Name: Trobalt
INN or Proposed INN: RETIGABINE
Centre for Human Drug ResearchNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
28NCT02238626
(ClinicalTrials.gov)
September 20144/9/2014Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Single-center, Randomized, Double-blind, Placebo-controlled, 6-month Trial Followed by an Open-label Extension to Evaluate the Safety, Tolerability and Clinical Endpoint Responsiveness of Ibudilast (MN-166) in Subjects With (ALS)Amyotrophic Lateral SclerosisDrug: Placebo (for MN-166);Drug: MN-166;Drug: riluzoleMediciNovaAtrium HealthCompleted18 Years80 YearsAll71Phase 2United States
29NCT02645461
(ClinicalTrials.gov)
January 201422/12/2015Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALSAcetylcholine Receptors From Human Muscles as Pharmacological Target for ALSAmyotrophic Lateral SclerosisDrug: endocannabinoid palmitoylethanolamide (PEA);Drug: RiluzoleUniversity of Roma La SapienzaNULLCompleted18 YearsN/ABoth50N/ANULL
30EUCTR2012-004987-23-ES
(EUCTR)
12/06/201316/05/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;France;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
31NCT01879241
(ClinicalTrials.gov)
June 201312/6/2013Study of Rasagiline in Patients With Amyotrophic Lateral SclerosisEfficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized SubstanceAmyotrophic Lateral SclerosisDrug: Rasagiline;Drug: PlaceboUniversity of UlmNULLCompleted18 YearsN/ABoth252Phase 2Germany
32EUCTR2012-004987-23-DE
(EUCTR)
29/04/201317/01/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
33EUCTR2011-004482-32-DE
(EUCTR)
10/04/201321/12/2012Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - RAS-ALS Trial Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: AZILECT® 1 mg Tabletten
INN or Proposed INN: Rasagiline Mesilate
Other descriptive name: RASAGILINE MESILATE
Universitätsklinikum UlmNULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany
34NCT02588677
(ClinicalTrials.gov)
April 201320/10/2015Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of MasitinibAmyotrophic Lateral Sclerosis (ALS)Drug: Masitinib (4.5);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (3.0)AB ScienceNULLCompleted18 YearsN/AAll394Phase 2/Phase 3Spain
35EUCTR2012-004987-23-IE
(EUCTR)
08/02/201330/11/2012A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
36EUCTR2012-004987-23-GB
(EUCTR)
24/01/201312/12/2012A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
37NCT01709149
(ClinicalTrials.gov)
October 201216/10/2012Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS)Amyotrophic Lateral SclerosisDrug: CK-2017357;Other: Placebo tablets;Drug: RiluzoleCytokineticsNULLCompleted18 YearsN/AAll711Phase 2United States;Canada;France;Germany;Ireland;Netherlands;Spain;United Kingdom
38NCT01486849
(ClinicalTrials.gov)
November 201123/11/2011Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose Titration Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: CK-2017357;Drug: Placebo;Drug: Riluzole 50 MGCytokineticsNULLCompleted18 YearsN/AAll27Phase 2United States
39JPRN-UMIN000006423
2011/10/0101/10/2011The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis amyotrophic lateral sclerosisadministration of mexiletine and riluzole
administration of riluzole only
Department of Neurology, Graduate School of Medicine, Chiba University, Japan.NULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not selectedJapan
40NCT01378676
(ClinicalTrials.gov)
June 201120/6/2011A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Placebo (Part A);Drug: CK-2017357 (Part A);Drug: Riluzole 50 MG (Part B);Drug: Placebo (Part B);Drug: CK-2017357 (Part B)CytokineticsNULLCompleted18 YearsN/AAll49Phase 2United States
41EUCTR2010-021179-10-GB
(EUCTR)
18/04/201131/01/2011An Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzoleAn Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzole Disease under investigation : Amyotrophic lateral Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: Olesoxime
Other descriptive name: 4 cholesten-3-one, oxime
TROPHOSNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Spain
42EUCTR2010-021179-10-DE
(EUCTR)
15/03/201112/11/2010An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. Amyotrophic Lateral Sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS
Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
Spain;Germany;United Kingdom
43NCT00876772
(ClinicalTrials.gov)
March 20116/4/2009Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)Randomized, Placebo-controlled Parallel Group Study for the Evaluation of an Oral Dose of 10mg Olanzapine in Combination With Riluzole for the Treatment of Loss of Appetite in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: OlanzapineCharite University, Berlin, GermanyNULLRecruiting18 Years80 YearsBoth40Phase 2/Phase 3Germany
44NCT01277315
(ClinicalTrials.gov)
February 201113/1/2011Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral SclerosisOpen Safety and Tolerability Trial to Evaluate a Subcutaneous Injection Solution of 100 mg of Anakinra in Combination With Riluzol in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: AnakinraCharite University, Berlin, GermanyMax Planck Institute for Infection BiologyRecruiting18 Years80 YearsBoth20Phase 2Germany
45EUCTR2010-021179-10-BE
(EUCTR)
28/01/201105/01/2011An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. Amyotrophic Lateral Sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS
Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
Phase 2;Phase 3Spain;Belgium;Germany;United Kingdom
46NCT01285583
(ClinicalTrials.gov)
October 201026/1/2011Safety Extension Study of TRO19622 in ALSAn Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With RiluzoleAmyotrophic Lateral SclerosisDrug: TRO19622Hoffmann-La RocheNULLCompletedN/AN/ABoth271Phase 2/Phase 3Belgium;France;Germany;Spain;United Kingdom
47EUCTR2008-007320-25-ES
(EUCTR)
10/08/200916/07/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol.Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. ESCLEROSIS LATERAL AMIOTRÓFICA.ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles due to destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: TRO19622
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2France;Belgium;Spain;Germany;United Kingdom
48EUCTR2008-007320-25-GB
(EUCTR)
24/07/200914/04/2009 Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. Disease under investigation : Amyotrophic lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral Sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOSNULLNot Recruiting Female: yes
Male: yes
470 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Belgium;Germany;United Kingdom
49EUCTR2008-007320-25-DE
(EUCTR)
24/06/200918/02/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2/3United Kingdom;Germany;Belgium;France;Spain
50EUCTR2008-006722-34-IT
(EUCTR)
23/06/200911/12/2008Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS LithiumMulticentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium Amyotrophic Lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: CARBOLITHIUM
INN or Proposed INN: Lithium
ISTITUTO SUPERIORE DI SANITA`NULLNot RecruitingFemale: yes
Male: yes
Italy
51EUCTR2008-007320-25-BE
(EUCTR)
08/06/200928/04/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3France;Spain;Belgium;Germany;United Kingdom
52NCT00868166
(ClinicalTrials.gov)
April 30, 200923/3/2009Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALSPhase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With RiluzoleAmyotrophic Lateral SclerosisDrug: Olesoxime;Drug: Placebo Comparator;Drug: RiluzoleHoffmann-La RocheEuropean CommissionCompleted18 Years80 YearsAll512Phase 3Belgium;France;Germany;Spain;United Kingdom;Netherlands
53EUCTR2009-010060-41-IT
(EUCTR)
24/02/200906/03/2009Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - NDEvaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND Amyotrophic Lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: LITIO CARBONATO
INN or Proposed INN: Lithium
Trade Name: RILUTEK
INN or Proposed INN: Riluzole
AZIENDA OSPEDALIERA PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
54EUCTR2008-007320-25-FR
(EUCTR)
17/02/200916/03/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3France;Spain;Belgium;Germany;United Kingdom
55NCT00818389
(ClinicalTrials.gov)
January 20096/1/2009Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in Combination With Riluzole in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Lithium Carbonate;Drug: Riluzole;Drug: placeboMassachusetts General HospitalALS Association;ALS Society of Canada;National Institute of Neurological Disorders and Stroke (NINDS);University of Toronto;State University of New York - Upstate Medical University;Columbia University;University of KentuckyTerminated18 YearsN/AAll84Phase 2/Phase 3United States;Canada
56EUCTR2007-003775-39-DE
(EUCTR)
29/10/200809/09/2008Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite lossRandomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite loss patients with amyotrophic lateral sclerosisTrade Name: Zyprexa
INN or Proposed INN: OLANZAPINE
Charité – Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes
Germany
57EUCTR2008-002110-22-NL
(EUCTR)
16/09/200805/08/2008A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALSA randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS Amyotrophic lateral sclerosis (ALS) is a disease characterised by progressive degeneration of motor neurons in brain and spinal cord leading to muscle weakness. ALS can occur at anytime in adulthood. Muscle weakness gradually progresses. Approximately 50% of patients die within 3 years after onset of symptoms, usually as the result of respiratory failure. To date, only one drug, i.e. riluzole, has proven to extend survival in patients with ALS, but only by approximately 3 to 6 months.
MedDRA version: 9.1;Level: LLT;Classification code 10052889;Term: ALS
Trade Name: Lithiumcarbonaat 400 PCH tabletten
Product Name: Lithiumcarbonaat
Other descriptive name: LITHIUM CARBONATE
Prof. dr L.H. van den Berg, UMC-UtrechtNULLNot RecruitingFemale: yes
Male: yes
Netherlands
58NCT00690118
(ClinicalTrials.gov)
May 20082/6/2008Study of Pioglitazone in Patients With Amyotrophic Lateral SclerosisEfficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)Amyotrophic Lateral SclerosisDrug: pioglitazone;Drug: placeboUniversity of UlmNULLTerminated18 YearsN/ABoth219Phase 2Germany;Italy
59EUCTR2006-005410-13-DE
(EUCTR)
22/04/200821/01/2008EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE).EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE). Male or female adult patients with amyotrophic lateral sclerosis (ALS) accoring to the El Escorial Criteria for the diognosis of ALS and treated for at least 3 month with 100 mg riluzole (standard therapy).
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Actos 15 mg
INN or Proposed INN: Pioglitazone
Trade Name: Actos 30 mg
INN or Proposed INN: Pioglitazone
Trade Name: Actos 45 mg
INN or Proposed INN: Pioglitazone
University Hospital of UlmNULLNot RecruitingFemale: yes
Male: yes
Germany
60EUCTR2006-002660-26-NL
(EUCTR)
17/04/200703/01/2007A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
61NCT00635960
(ClinicalTrials.gov)
March 20073/3/2008Growth Hormone in Amyotrophic Lateral SclerosisEfficacy, Safety and Tolerability of Growth Hormone in Patients With Amyotrophic Lateral Sclerosis as add-on Therapy to RiluzoleAmyotrophic Lateral SclerosisDrug: Growth Hormone (Somatropin);Drug: PlaceboFederico II UniversityIstituto Biostrutture e Immagini, CNR Naples;Agenzia Italiana del FarmacoCompleted40 Years85 YearsBoth40Phase 2Italy
62EUCTR2006-002660-26-IT
(EUCTR)
01/02/200710/11/2006A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - NDA MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506ONO PHARMA UK LTDNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
63EUCTR2006-002660-26-GB
(EUCTR)
08/01/200720/09/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
64EUCTR2006-002660-26-DE
(EUCTR)
20/12/200619/01/2007A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria
65EUCTR2006-002660-26-FR
(EUCTR)
12/12/200610/10/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Phase 2France;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
66EUCTR2006-002660-26-BE
(EUCTR)
13/11/200628/09/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
67EUCTR2006-002660-26-AT
(EUCTR)
13/11/200606/11/2006A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATIONA MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION Amyotrophic Lateral Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: ONO-2506PO
Product Code: ONO-2506PO
INN or Proposed INN: Arundic Acid
Other descriptive name: (2R)-2-Propyloctanoic acid
ONO Pharmaceutical Co.,LtdNULLNot RecruitingFemale: yes
Male: yes
392Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria
68NCT00403104
(ClinicalTrials.gov)
November 200622/11/2006Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of RandomizationAmyotrophic Lateral Sclerosis (ALS)Drug: ONO-2506POOno Pharmaceutical Co. LtdNULLCompleted18 Years74 YearsBoth420Phase 2Austria;Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
69NCT00231140
(ClinicalTrials.gov)
December 200530/9/2005Pilot-Study of Thalidomide in Amyotrophic Lateral Sclerosis (ALS)Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Thalidomide (drug)Charite University, Berlin, GermanyNULLTerminated25 Years80 YearsBoth40Phase 2Germany
70NCT00353665
(ClinicalTrials.gov)
July 200518/7/2006Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)Phase 2-3 - Memantine for Disability in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Memantine (Ebixa);Drug: riluzole;Drug: PlaceboUniversity of LisbonH. Lundbeck A/SCompleted20 Years75 YearsBoth63Phase 2/Phase 3Portugal
71NCT01020331
(ClinicalTrials.gov)
June 200520/11/2009Memantine Therapy in Amyotrophic Lateral SclerosisPhase IIA Open Label Trial of Memantine in Combination With Riluzole (Customary Care) for the Treatment of ALSAmyotrophic Lateral SclerosisDrug: MemantinePhoenix Neurological Associates, LTDForest LaboratoriesCompleted18 Years85 YearsBoth20Phase 2United States
72EUCTR2004-002390-23-DE
(EUCTR)
24/11/200430/11/2004Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjectsEvaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects amyotrophic lateral sclerosis
Classification code 10002026
Trade Name: RILUTEK
Product Name: RILUTEK 50 mg, film-coated tablets
INN or Proposed INN: riluzole
Aventis Pharma Ltd.NULLNot RecruitingFemale:
Male: yes
Germany
73NCT00542412
(ClinicalTrials.gov)
January 200110/10/2007CARE Canadian ALS Riluzole EvaluationCare (Canadian ALS Riluzole Evaluation) Multicentre Phase IV Comparative Study of the Effects of Riluzole 50mg Bid on the Survival of ALS Subjects Compared to Historical ControlsAmyotrophic Lateral SclerosisDrug: RiluzoleSanofiNULLCompleted18 Years75 YearsBoth414Phase 4Canada
74EUCTR2019-001862-13-IE
(EUCTR)
04/08/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Masitinib 100mg
Product Code: AB1010
INN or Proposed INN: Masitinib Mesylate
Product Name: Masitinib 200mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
75EUCTR2019-001862-13-GB
(EUCTR)
24/03/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Masitinib 100mg
Product Code: AB1010
INN or Proposed INN: Masitinib Mesylate
Other descriptive name: na
Product Name: Masitinib 200mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLNAFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
76EUCTR2012-004987-23-NL
(EUCTR)
07/02/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
680Phase 2France;United States;Canada;Spain;Ireland;Germany;Netherlands;United Kingdom
77EUCTR2010-024423-24-IE
(EUCTR)
06/11/2014A controlled clinical study to investigate the effectiveness and safety of the medicine called masitinib when used together with a currently available medicine Riluzole when treating the illness called Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 Study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS). - IRELAND Phase 2/3 study comparing Masitinib/Placebo in ALS Amyotrophic lateral Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Masitinib 100 mg Tablets
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: SUB126308
Product Name: Masitinib 200 mg Tablets
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: SUB126308
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Argentina;Belgium;Romania;Netherlands;Germany