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

  
89 trials found
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PhaseCountries
1NCT05281484
(ClinicalTrials.gov)
April 20227/3/2022Intermediate Expanded Access Protocol (EAP) CNMAu8.EAP02A Second Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8Amyotrophic Lateral SclerosisDrug: CNM-Au8Clene NanomedicineNULLAvailable18 YearsN/AAllUnited States
2NCT05286372
(ClinicalTrials.gov)
April 20229/3/2022An Intermediate Size Expanded Access Protocol of AMX0035 for ALSAn Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: AMX0035Amylyx Pharmaceuticals Inc.NULLAvailable18 YearsN/AAllNULL
3JPRN-jRCT2071210117
23/02/202221/01/2022Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALSA Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis- Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country
- Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to
48 weeks or until the drug is commercially available in that country
Kondo KazuokiNULLRecruiting>= 18age oldNot applicableBoth300Phase 3US;Canada;Germany;Italia;South Korea;Switzerland;Japan
4EUCTR2019-001862-13-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
5NCT04889898
(ClinicalTrials.gov)
January 1, 20227/5/2021Remote Speech and Swallowing Assessment in ALSHome Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALSAmyotrophic Lateral SclerosisDevice: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone;Radiation: Modified Barium Swallow Study (MBSS);Behavioral: Speech Intelligibility Test (SIT);Behavioral: SIT ScoringMilton S. Hershey Medical CenterPenn State University;Congressionally Directed Medical Research ProgramsRecruiting18 YearsN/AAll170United States
6NCT05163886
(ClinicalTrials.gov)
December 23, 202117/11/2021Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral SclerosisA Phase IIa Trial to Evaluate the Safety, Tolerability, and Biological Activity of LAM-002A (Apilimod Dimesylate Capsules) in C9ORF72-Associated Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;ALSDrug: LAM-002A;Other: PlaceboAI Therapeutics, Inc.NULLRecruiting18 YearsN/AAll12Phase 2United States
7NCT05039268
(ClinicalTrials.gov)
November 25, 202123/8/20213K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)A Phase 2 Open Label Trial of 3K3A-APC in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: 3K3A-APC ProteinMacquarie University, AustraliaZZ Biotech, LLCRecruiting18 Years75 YearsAll16Phase 2Australia
8EUCTR2019-001862-13-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
9NCT05039099
(ClinicalTrials.gov)
September 2, 20211/9/2021A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacodynamic Markers, and Pharmacokinetics of AP-101 in Patients With Familial Amyotrophic Lateral Sclerosis (fALS) and Sporadic Amyotrophic Lateral Sclerosis (sALS)Amyotrophic Lateral SclerosisDrug: AP-101;Drug: PlaceboAL-S PharmaNULLRecruiting18 YearsN/AAll63Phase 2United States;Canada;Germany;Korea, Republic of;Sweden
10EUCTR2019-003797-10-NL
(EUCTR)
23/07/202109/11/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Netherlands;Germany;Japan
11EUCTR2019-003797-10-CZ
(EUCTR)
13/05/202127/10/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan
12NCT03843710
(ClinicalTrials.gov)
April 30, 202114/2/201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Gold NanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterNot yet recruiting35 Years75 YearsAll24Phase 2United States
13EUCTR2019-003797-10-IE
(EUCTR)
06/04/202103/09/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Australia;Germany;Netherlands;Japan
14EUCTR2019-003797-10-DE
(EUCTR)
18/02/202112/10/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan
15EUCTR2019-001862-13-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
16EUCTR2019-001862-13-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
17EUCTR2019-003797-10-IT
(EUCTR)
03/02/202128/07/2021A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter studyto evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) - MERIDIAN Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplam
Product Code: [APL-2]
Other descriptive name: N/A
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan
18JPRN-jRCT2041200084
23/12/202024/12/2020Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral SclerosisOral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free periodKondo KazuokiNULLRecruiting>= 18age oldNot applicableBoth140Phase 3United States of America;Canada;Germany;France;Italy;Japan
19EUCTR2019-001862-13-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
20EUCTR2019-001862-13-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
21NCT04579666
(ClinicalTrials.gov)
September 30, 202022/9/2020MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: Pegcetacoplan (APL-2);Other: PlaceboApellis Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll228Phase 2United States;Australia;Belgium;Czechia;France;Germany;Ireland;Italy;Japan;Netherlands;Poland;Spain;Ukraine;United Kingdom
22EUCTR2019-001862-13-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
23NCT04288856
(ClinicalTrials.gov)
April 28, 202026/2/2020Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: BIIB078BiogenNULLActive, not recruiting18 YearsN/AAll90Phase 1United States;Canada;Netherlands;Switzerland;United Kingdom
24NCT04326283
(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
25EUCTR2019-001862-13-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
26NCT04220021
(ClinicalTrials.gov)
January 10, 20203/1/2020Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTDA Single-Center, Open Label Study to Assess the Safety and Tolerability of Metformin in Subjects With C9orf72 Amyotrophic Lateral Sclerosis Over 24 Weeks of TreatmentC9orf72 Amyotrophic Lateral Sclerosis (ALS);Frontotemporal DementiaDrug: MetforminUniversity of FloridaNULLRecruiting18 Years80 YearsAll18Phase 2United States
27NCT03981536
(ClinicalTrials.gov)
October 10, 201930/5/2019A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)A Multicenter, Open Label, Single-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: AP-101AL-S PharmaNULLActive, not recruiting18 YearsN/AAll18Phase 1Canada
28ChiCTR1900024520
2019-07-222019-07-13Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosisSplit-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis Amyotrophic lateral sclerosisGold Standard:Clinical outcome meet the Awaji-Shima Criteria 2008;Index test:Split-hand index calculated by F-wave test;Peking Union Medical College HospitaNULLRecruiting1880BothTarget condition:300;Difficult condition:50N/AChina
29EUCTR2019-000374-39-IT
(EUCTR)
15/07/201927/01/2021Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial - na Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: [BRX-345]
INN or Proposed INN: ARIMOCLOMOL
ORPHAZYME APSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
30NCT04176224
(ClinicalTrials.gov)
April 17, 201922/11/2019Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral SclerosisClinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)Japanese Patients With ALSDrug: MT-1186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years75 YearsAll9Phase 1Japan
31NCT03693781
(ClinicalTrials.gov)
April 10, 201930/9/2018Colchicine for Amyotrophic Lateral SclerosisColchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical TrialAmyotrophic Lateral SclerosisDrug: Colchicine 1 MG Oral Tablet;Drug: Placebo Oral TabletAzienda Ospedaliero-Universitaria di ModenaUniversity of Modena and Reggio Emilia;University of Turin, Italy;Istituto Auxologico Italiano;IRCCS National Neurological Institute C. Mondino Foundation;University of Bari;IRCCS San Raffaele;University of Padova;University of Milan;Istituto Di Ricerche Farmacologiche Mario Negri;University of Campania Luigi Vanvitelli;Catholic University of the Sacred HeartActive, not recruiting18 Years80 YearsAll54Phase 2Italy
32NCT04081714
(ClinicalTrials.gov)
April 1, 20195/9/2019Intermediate Expanded Access Protocol for ALSAn Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8Amyotrophic Lateral SclerosisDrug: CNM-Au8Clene NanomedicineMassachusetts General HospitalAvailable18 YearsN/AAllUnited States
33NCT02437110
(ClinicalTrials.gov)
April 1, 20195/5/2015HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Darunavir;Drug: Ritonavir;Drug: Dolutegravir;Drug: Tenofovir alafenamide (TAF)National Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll200Phase 1United States
34JPRN-UMIN000036295
2019/03/2926/03/2019Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS)Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral SclerosisThe study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period.
3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design.
Center for iPS Cell Research and Application, Kyoto UniversityProvider of the investigational product: Pfizer Japan Inc.Complete: follow-up complete20years-old80years-oldMale and Female24Phase 1Japan
35JPRN-JMA-IIA00419
29/03/201929/03/2019Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS)Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral SclerosisIntervention type:DRUG. Intervention1:Medicine, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. .Center for iPS Cell Research and Application (CiRA), Kyoto UniversityNULLRecruiting>=20 YEARS<80 YEARSBOTH24Phase 1Japan
36EUCTR2018-000137-13-IT
(EUCTR)
08/10/201822/01/2021A study to compare the use of Arimoclomol with placebo in patients withAmyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis - na Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: [BRX-345]
INN or Proposed INN: ARIMOCLOMOL
ORPHAZYME APSNULLNot RecruitingFemale: yes
Male: yes
231Phase 3France;United States;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
37NCT03482050
(ClinicalTrials.gov)
April 12, 201814/3/2018A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase I/IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Theraputic Effects of Transplantation of Astrocytes Derived From Human Embryonic Stem Cells (hESC), in Patients With Amyotrophic Lateral Sclerosis (ALS)ALS (Amyotrophic Lateral Sclerosis)Biological: AstroRxKadimastemNULLCompleted18 Years70 YearsAll16Phase 1/Phase 2Israel
38NCT03334786
(ClinicalTrials.gov)
April 5, 201826/10/2017Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALSAn Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and One Appendicular Muscle in Adult Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;FasciculationDrug: FLX-787-ODTFlex Pharma, Inc.NULLTerminated18 YearsN/AAll3Phase 1/Phase 2United States
39NCT03679975
(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
40JPRN-UMIN000029308
2017/07/1830/09/2018Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination. Amyotrophic lateral sclerosisFebuxostat 20 mg, Inosine 500 mg, twice a day for 14 daysTeikyo UniversityNULLComplete: follow-up complete20years-old80years-oldMale and Female3Not applicableJapan
41JPRN-jRCTs031180173
07/07/201701/03/2019Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis amyotrophic lateral sclerosis
amyotrophic lateral sclerosis;G122
gradual increase of lacosamide from 100mg to 400mg for 4 weeksKuwabara SatoshiNULLComplete>= 20age oldNot applicableBoth30Phase 1-2Japan
42JPRN-UMIN000027476
2017/06/0101/06/2017Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis - Open-label clinical trial of lacosamide in ALS amyotrophic lateral sclerosisgradual increase of lacosamide from 100mg to 400mg for 4 weeksDepartment of Neurology Chiba University HospitalNULLComplete: follow-up continuing20years-oldNot applicableMale and Female30Not selectedJapan
43NCT03019419
(ClinicalTrials.gov)
April 24, 201710/1/2017Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 TrialsALSDrug: Perampanel;Drug: placeboTokyo Medical UniversityNULLCompleted40 Years78 YearsAll66Phase 2Japan
44NCT03103815
(ClinicalTrials.gov)
April 24, 20171/4/2017Trial of Amivita in Amyotrophic Lateral SclerosisTrial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical TrialAmyotrophic Lateral SclerosisDrug: AmivitaWujin People's HospitalNanjing 1718 Biotech Co. LtdRecruiting18 Years70 YearsAll30N/AChina
45NCT03049046
(ClinicalTrials.gov)
April 7, 20173/2/2017CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALSProtocol CC100B. CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALSAmyotrophic Lateral SclerosisDrug: CC100;Drug: PlacebosChemigen, LLCNULLRecruiting18 Years64 YearsAll21Phase 1United States
46NCT02943850
(ClinicalTrials.gov)
April 1, 201720/10/2016CNS10-NPC-GDNF for the Treatment of ALSHuman Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Stem cell (HPC) implantation;Device: Stereotactic surgical deviceCedars-Sinai Medical CenterCalifornia Institute for Regenerative Medicine (CIRM)Completed18 YearsN/AAll18Phase 1United States
47JPRN-UMIN000026221
2017/03/0201/03/2017Safety of perampanel in patients with motor neuron disease amyotrophic lateral sclerosisOnce daily perampanel with dose escalation from 2mg to 8mg.Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female15Phase 1Japan
48JPRN-UMIN000024854
2016/11/1616/11/2016Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosisClinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis - Clinical study for the anti-oxidative stress by edaravone in ALS Amyotrophic Lateral Sclerosis (ALS)Edaravone treatment for ALS patientsOkayama universityNULLComplete: follow-up complete20years-old75years-oldMale and Female20Not applicableJapan
49NCT03241784
(ClinicalTrials.gov)
May 16, 201627/7/2017T-Regulatory Cells in Amyotrophic Lateral SclerosisExpansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis)Biological: Autologous T-regulatory lymphocytes;Biological: Interleukin-2Stanley H. Appel, MDNULLUnknown status18 YearsN/AAll4Phase 1United States
50NCT02710162
(ClinicalTrials.gov)
April 201629/2/2016Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)Determination of Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDevice: Micro Mouth Pressure Meter;Device: Iowa Oral Performance Instrument;Device: Electrical Impedance Myography;Drug: Capsaicin;Procedure: Videofluoroscopic Swallowing Study;Procedure: Pulmonary Function Testing;Other: Swallowing Related Quality of Life Questionnaire;Other: Functional Oral Intake Scale;Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised;Other: Eating Assessment Tool-10;Other: Communicative Effectiveness Survey;Other: The Center for Neurologic Studies Bulbar Function ScaleUniversity of FloridaNULLCompleted21 Years85 YearsAll21Early Phase 1United States
51NCT02710110
(ClinicalTrials.gov)
April 201626/2/2016Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDevice: PowerLung trainer;Device: Micro Mouth Pressure Meter;Procedure: Pulmonary Function Testing;Procedure: Videofluoroscopic swallowing study;Other: Swallowing Quality of Life Questionnaire;Device: Iowa Oral Pressure Instrument;Drug: CapsaicinUniversity of FloridaALS AssociationCompleted21 Years85 YearsAll50Early Phase 1United States
52NCT02709330
(ClinicalTrials.gov)
April 20165/3/2016ALS Reversals - Lunasin RegimenAn Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)ALS (Amyotrophic Lateral Sclerosis)Drug: Lunasin Regimen;Other: Historical controlRichard Bedlack, M.D., Ph.D.NULLCompleted18 YearsN/AAll60Phase 2United States
53NCT02881476
(ClinicalTrials.gov)
November 201522/4/2016Therapeutic Treatment of Amyotrophic Lateral SclerosisApplication of Wharton's Jelly-derived Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisOther: Biological: Cell-based therapyUniversity of Warmia and MazuryNULLEnrolling by invitation18 Years65 YearsBoth30Phase 1NULL
54JPRN-UMIN000019111
2015/10/0101/10/2015CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. Amyotrophic lateral sclerosisAbound(TM)
1,Take one pack twice a day in the moring and evening
2,Drinking was dissolved in water 240 ~ 300ml
3,Before meals, after meals does not matter
4,12 weeks
National Hospital Organization Takasaki General Medical CenterNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
55EUCTR2010-024423-24-NL
(EUCTR)
21/09/201509/09/2015Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
56NCT02987413
(ClinicalTrials.gov)
April 28, 20151/7/2016Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis PatientsSafety and Efficacy of Mesenchymal Stem Cells Escalated Application in Amyotrophic Lateral Sclerosis Patients: Study Design of a Phase I TrialMotor Neuron DiseaseBiological: Autologous Mesenchymal stem cells (MSCs)Hospital e Maternidade Dr. Christóvão da GamaIEP São Lucas - Instituto de Ensino e Pesquisa;Clinica Jordy Sinapse;TECHLIFE - Centro de Tecnologia CelularCompleted18 YearsN/AAll3Phase 1Brazil
57EUCTR2010-024423-24-HU
(EUCTR)
21/04/201531/10/2014Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
300Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Germany;Netherlands
58EUCTR2010-024423-24-PT
(EUCTR)
10/04/201503/11/2014Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot Recruiting Female: yes
Male: yes
381 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
59NCT02463825
(ClinicalTrials.gov)
April 201521/4/2015A Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALSA Registry-Based Randomized-Controlled, Double-Blinded Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: Pimozide 2 mg per day;Drug: Pimozide 4 mg per day;Drug: Placebo (Lactose tablet)University of CalgaryHotchkiss Brain Institute, University of CalgaryActive, not recruiting18 YearsN/ABoth25Phase 2Canada
60EUCTR2010-024423-24-GR
(EUCTR)
06/03/201521/11/2013Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable Patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3United States;Portugal;Slovakia;Greece;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Netherlands;Germany
61JPRN-UMIN000016352
2015/02/0101/02/2015The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial amyotrophic lateral sclerosisedaravoneEhime University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Phase 1,2Japan
62EUCTR2012-002099-15-SE
(EUCTR)
15/09/201401/08/2014Safety and Efficacy of Apovir for treatment of patients with ALS (Amyotrophic lateral sclerosis)A randomised, double blind, placebo controlled trial to evaluate the safety and efficacy of Apovir for treatment of patients with Amyotrophic lateral sclerosis Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pleconaril
Product Code: APO-P001
INN or Proposed INN: PLECONARIL
Trade Name: Copegus
Product Name: Ribavirin
Other descriptive name: RIBAVIRIN
Apodemus ABNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
63EUCTR2010-024423-24-SK
(EUCTR)
07/04/201405/12/2013Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
64NCT02166944
(ClinicalTrials.gov)
April 20149/6/2014Tamoxifen Treatment in Patients With Motor Neuron DiseaseThe Study of Tamoxifen Treatment in Patients With Motor Neuron DiseaseAmyotrophic Lateral Sclerosis;ALS Functional Ration Scale;TAR-DNA-binding Protein-43;Tamoxifen;mTORDrug: tamoxifen 40 mg daily for one yearTaipei Medical University Shuang Ho HospitalNULLCompleted20 Years80 YearsAll20Phase 1/Phase 2Taiwan
65JPRN-UMIN000011494
2013/09/0202/09/2013Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling amyotrophic lateral sclerosisscopolamine patch 7days-washout 7days-placebo patch 7days
placebo patch 7days-washout 7days-scopolamine patch 7days
Mie University Graduate school of medicine,Department of neurologyMatsusaka Chuou HospitalNational Mie HospitalComplete: follow-up completeNot applicableNot applicableMale and Female10Not applicableJapan
66NCT02164253
(ClinicalTrials.gov)
September 201320/5/2014Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) PatientsFeasibility and Safety Pilot Therapeutic Study of the Iron Chelator Deferiprone in Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis);Iron OverloadDrug: DeferiproneUniversity Hospital, LilleApoPharmaCompleted18 Years85 YearsAll23Phase 2France
67NCT01806857
(ClinicalTrials.gov)
April 20135/3/2013Clinical Trial Nuedexta in Subjects With ALSThe Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Nuedexta;Drug: Matching PlaceboCenter for Neurologic Study, La Jolla, California,ALS Association;State University of New York - Upstate Medical UniversityCompleted18 YearsN/AAll90Phase 2United States
68NCT02588677
(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
69EUCTR2010-024423-24-ES
(EUCTR)
29/01/201329/11/2012Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: MASITINIB
ABScienceNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy
70JPRN-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
71NCT00876772
(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
72NCT02880033
(ClinicalTrials.gov)
February 20113/8/2016Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating LymphocytesModulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral SclerosisParkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron OverloadDrug: deferiprone;Drug: placeboUniversity Hospital, LilleNULLCompleted18 Years80 YearsAll90N/AFrance
73EUCTR2008-003982-21-FR
(EUCTR)
10/06/201014/01/2010Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALSEtude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALS Patients présentant une SLA et volontaires sains
MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: DaTSCAN
Product Name: Datscan
INN or Proposed INN: Ioflupane 123I
Product Name: [I-123] ADAM
INN or Proposed INN: [I-123] ADAM
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
France
74EUCTR2008-007320-25-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
75JPRN-UMIN000002276
2009/08/0101/08/2009Developmental research of communication devices based on the brain machine interface using electroencephalograms amyotrophic lateral sclerosisLet the patients use the communication devices to select characters on a computer monitor as they intend by recording EEG.Osaka UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Not applicableJapan
76EUCTR2008-007320-25-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
77EUCTR2008-007320-25-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
78NCT00868166
(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
79NCT00886977
(ClinicalTrials.gov)
April 200921/4/2009Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: YAM80Yoshino Neurology ClinicNULLActive, not recruiting25 Years65 YearsBoth25Phase 2Japan
80EUCTR2008-006891-31-GB
(EUCTR)
17/02/200928/07/2010A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALSA randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Lithium Apogepha
Product Name: Lithium Carbonate
Other descriptive name: LITHIUM CARBONATE
Trade Name: Lithium Carbonate
Product Name: Lithium Carbonate
Other descriptive name: LITHIUM CARBONATE
Trade Name: Lithium Citrate
Product Name: Lithium Citrate
Other descriptive name: LITHIUM CITRATE
King's College LondonNULLNot RecruitingFemale: yes
Male: yes
220Phase 4United Kingdom
81EUCTR2008-007320-25-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
82EUCTR2007-003775-39-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
83EUCTR2008-003707-32-FR
(EUCTR)
09/10/200822/08/2008Etude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLAEtude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLA Patient atteint de sclérose latérale amyotrophique.
MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Téralithe LP
Product Name: Téralithe LP
INN or Proposed INN: Carbonate de lithium
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
84EUCTR2008-002110-22-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
85NCT00444613
(ClinicalTrials.gov)
April 20076/3/2007A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: E0302 (mecobalamin);Drug: PlaceboEisai Co., Ltd.NULLCompleted20 YearsN/ABoth373Phase 2/Phase 3Japan
86NCT00136110
(ClinicalTrials.gov)
April 200524/8/2005Trial of Sodium Valproate in Amyotrophic Lateral SclerosisA Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALSAmyotrophic Lateral SclerosisDrug: Sodium ValproateUMC UtrechtPrincess Beatrix Fund, The NetherlandsCompleted18 Years85 YearsBoth165Phase 3Netherlands
87NCT00812851
(ClinicalTrials.gov)
April 200521/11/2008Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Cramps;Amyotrophic Lateral SclerosisDrug: DronabinolCantonal Hospital of St. GallenALS AssociationCompleted18 YearsN/ABoth24N/ASwitzerland
88NCT00243932
(ClinicalTrials.gov)
April 200524/10/2005Clinical Trial of High Dose CoQ10 in ALSClinical Trial of High Dose CoQ10 in ALSAmyotrophic Lateral Sclerosis;Lou Gehrig's DiseaseDrug: coenzyme Q10;Drug: PlaceboColumbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed21 Years85 YearsAll185Phase 2United States
89NCT00107770
(ClinicalTrials.gov)
April 20057/4/2005Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: sodium phenylbutyrateDepartment of Veterans AffairsMuscular Dystrophy AssociationCompleted18 YearsN/ABoth40Phase 1/Phase 2United States