2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2071220047 | 26/08/2022 | 27/08/2022 | Formulation Pharmacokinetics Study of EPI-589 | Formulation Pharmacokinetics Study of EPI-589 (DA350102) | Amyotrophic lateral sclerosis | Subjects receive a test formulation (containing 1000 mg of EPI-589) or a reference formulation (containing 1000 mg of EPI-589) once orally in period 1 and period 2. | Hamatani Tatsuto | NULL | Recruiting | >= 20age old | < 55age old | Male | 24 | Phase 1 | Japan |
| 2 | JPRN-jRCT2061210031 | 04/10/2021 | 27/08/2021 | EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALS | EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALS - EPIC-ALS | Amyotrophic Lateral Sclerosis | EPI-589 500 mg (2 tablets of EPI-589 250 mg) is orally administered three times a day before meals (at least one hour before breakfast, lunch, and dinner). The treatment period will be from the day after the registration of the treatment period to the end of the examination at 24 weeks of the treatment period. | Fujita Koji | NULL | Not Recruiting | >= 18age old | <= 79age old | Both | 10 | Phase 2 | Japan |
| 3 | JPRN-jRCT2071210023 | 17/05/2021 | 17/05/2021 | Clinical Pharmacology Study of EPI-589 | Clinical Pharmacology Study of EPI-589 (DA350101) | Amyotrophic lateral sclerosis | Cohort 1 : multiple oral administration, 750 mg, three times a day, EPI-589 or placebo Cohort 2 : multiple oral administration, 1000 mg, three times a day, EPI-589 or placebo Cohort 3 : multiple oral administration, 1250 mg, three times a day, EPI-589 or placebo Cohort 4 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo Cohort 5 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo | Hamatani Tatsuto | NULL | Recruiting | >= 20age old | <= 55age old | Male | 40 | Phase 1 | Japan |
| 4 | JPRN-jRCT2071210022 | 03/07/2018 | 12/05/2021 | Clinical Pharmacology Study of EPI-589 | Clinical Pharmacology Study of EPI-589 (DA301006) | Amyotrophic lateral sclerosis | Part A : Single oral administration (EPI-589 250, 500, 1000 mg/day or placebo) Part B : Single oral administration (EPI-589 500 mg/day or placebo) Part C : Multiple oral administration (EPI-589 1000, 1500 mg/day or placebo) Part D : Single oral administration (EPI-589 500 mg/day) | Hamatani Tatsuto | NULL | Complete | >= 20age old | <= 55age old | Male | 68 | Phase 1 | Japan |
| 5 | NCT02460679 (ClinicalTrials.gov) | January 14, 2016 | 21/5/2015 | Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: EPI-589 | PTC Therapeutics | NULL | Completed | 21 Years | 70 Years | All | 19 | Phase 2 | United States |