IBUDILAST ( DrugBank: Ibudilast )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症4
13多発性硬化症/視神経脊髄炎1

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04057898
(ClinicalTrials.gov)
May 28, 20206/8/2019Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALSA Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: MN-166;Drug: placeboMediciNovaNULLRecruiting18 Years80 YearsAll230Phase 2/Phase 3United States;Canada
2EUCTR2019-003549-14-HU
(EUCTR)
11/03/202013/01/2020A Clinical Trial To Evaluate The Efficacy And Safety Of Mn-166 (Ibudilast) In Subjects With Amyotrophic Lateral Sclerosis(Lou Gehrig's disease)A PHASE 2B/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12 MONTH CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MN-166 (IBUDILAST) FOLLOWED BY AN OPEN-LABEL EXTENSION IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS - COMBAT-ALS Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;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: Ibudilast
Product Code: MN-166
INN or Proposed INN: IBUDILAST
MediciNova, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 2;Phase 3United States;Hungary;Greece;Poland;Spain;Germany;Italy
3NCT02714036
(ClinicalTrials.gov)
May 6, 20169/3/2016A Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)A Multi-Center, Open-Label Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: ibudilastMediciNovaMassachusetts General Hospital;South Shore Neurologic AssociatesCompleted18 YearsN/AAll35Phase 1/Phase 2United States
4NCT02238626
(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

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01982942
(ClinicalTrials.gov)
November 201329/10/2013Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple SclerosisA Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple SclerosisMultiple Sclerosis, Primary Progressive;Multiple Sclerosis, Secondary ProgressiveDrug: ibudilast;Drug: Placebo oral capsuleMediciNovaNational Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS);National Multiple Sclerosis SocietyCompleted21 Years65 YearsAll255Phase 2United States