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

  
26 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-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
2EUCTR2020-003376-40-SE
(EUCTR)
23/02/202229/12/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
3EUCTR2020-003376-40-DE
(EUCTR)
26/10/202116/06/2021A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
4EUCTR2020-003376-40-IE
(EUCTR)
12/10/202110/06/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
5EUCTR2020-003376-40-ES
(EUCTR)
05/10/202123/06/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE (ALS Deceleration with ORal Edaravone) study Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Poland;Belgium;Spain;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy
6EUCTR2020-003376-40-IT
(EUCTR)
28/09/202119/10/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - - Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Edaravone
Product Code: [FAB122]
INN or Proposed INN: Edaravone
Other descriptive name: Norphenazone; methylphenylpyrazolone; norantipyrine; 3-methyl-1-phenyl-4, 5-dihydro-1H-pyrazol-5-one.
Ferrer Internacional S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
7EUCTR2020-003376-40-PL
(EUCTR)
18/08/202109/07/2021A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral SclerosisA multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;France;Spain;Belgium;Poland;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
8EUCTR2020-003376-40-BE
(EUCTR)
10/08/202108/06/2021A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: FAB122
INN or Proposed INN: EDARAVONE
Ferrer Internacional, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
9EUCTR2020-000376-38-DE
(EUCTR)
06/07/202119/01/2021A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: MT-1186
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Pharma Development America, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3France;United States;Canada;Germany;Italy;Japan
10EUCTR2019-004256-11-DE
(EUCTR)
11/05/202117/11/2020An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: MT-1186
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Pharma Development America, Inc. (MTDA)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of
11EUCTR2019-004256-11-IT
(EUCTR)
22/03/202124/05/2021An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - N/A Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: [MT-1186]
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of
12EUCTR2020-000376-38-IT
(EUCTR)
22/03/202124/05/2021A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - MT-1186-A03 Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: [MT-1186]
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Canada;Germany;Japan;Italy
13JPRN-jRCT2031200361
26/02/202115/02/2021Comparative Bioavailability study of Oral Edaravone Administered orally and via a Nasogastric TubeA Phase I, Randomized, Open-Label, Crossover-Design, Single-Dose Study to Investigate the Safety, Tolerability and Comparative Bioavailability of Oral Edaravone Administered orally and via a Nasogastric Tube (NGT) in Healthy Adult Subjects Amyotrophic Lateral SclerosisSubjects will receive the edaravone oral suspension orally. And, subjects will receive the edaravone oral suspension via a NGT.Kondo KazuokiNULLComplete>= 20age old<= 45age oldBoth36Phase 1Japan
14JPRN-jRCT2031200301
25/01/202115/01/2021Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALSA Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral SclerosisGroup 1: Oral edaravone administered once daily for 28 days, in Cycles 1 through 12
Group 2: Oral edaravone administered for 14 days, followed by placebo for 14 days in Cycle 1. Subsequently, repeat oral edaravone administered for 10 days followed by placebo for 18 days (regimen denoted as on/off) in Cycles 2 through 12
Kondo KazuokiNULLRecruiting>= 18age old<= 75age oldBoth380Phase 3Korea;Germany;United States of America;Canada;France;Switzerland;Italy;Japan
15JPRN-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
16NCT04569084
(ClinicalTrials.gov)
November 13, 202023/9/2020Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALSA Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)ALSDrug: MT-1186;Drug: PlaceboMitsubishi Tanabe Pharma Development America, Inc.NULLRecruiting18 Years75 YearsAll380Phase 3United States;Canada;Germany;Italy;Japan;Korea, Republic of;Switzerland
17NCT04391361
(ClinicalTrials.gov)
November 1, 202013/5/2020The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALSThe Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis;Respiratory Function;ScopolamineDrug: Scopolamine, atropine, edaravone and dexmedetomidine;Drug: EdaravoneRuijin HospitalNULLNot yet recruiting30 Years65 YearsAll30Phase 2China
18NCT04577404
(ClinicalTrials.gov)
October 29, 202030/9/2020Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: MT-1186Mitsubishi Tanabe Pharma Development America, Inc.NULLRecruiting18 YearsN/AAll140Phase 3United States;Canada;France;Germany;Italy;Japan
19EUCTR2019-002108-41-DE
(EUCTR)
06/05/202017/01/2020A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: MT-1186
INN or Proposed INN: EDARAVONE
Mitsubishi Tanabe Pharma Development America, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Canada;Germany;Italy;Japan
20EUCTR2019-002108-41-IT
(EUCTR)
24/04/202017/06/2021A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - n/a Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Edaravone
Product Code: [MT-1186]
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3France;United States;Canada;Germany;Japan;Italy
21NCT04254913
(ClinicalTrials.gov)
January 24, 202023/1/2020Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With GastrostomyClinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With GastrostomyJapanese Patients With ALSDrug: MT-1186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years80 YearsAll6Phase 1Japan
22NCT04259255
(ClinicalTrials.gov)
October 21, 201927/1/2020Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)Amyotrophic Lateral Sclerosis;ALSDrug: EdaravoneMitsubishi Tanabe Pharma America Inc.Massachusetts General HospitalRecruiting18 YearsN/AAll300United States;Canada
23NCT04176224
(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
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
25JPRN-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
26JPRN-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