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-jRCT2051220002 | 03/04/2022 | 08/04/2022 | Phase 1/2 Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1/2 Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Patients will receive bosutinib once daily, orally, for 24 weeks | Inoue Haruhisa | NULL | Recruiting | >= 20age old | <= 75age old | Both | 25 | Phase 2 | Japan |
| 2 | JPRN-JMA-IIA00419 | 29/03/2019 | 29/03/2019 | 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 Sclerosis | Intervention 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 University | NULL | Recruiting | >=20 YEARS | <80 YEARS | BOTH | 24 | Phase 1 | Japan |
| 3 | JPRN-jRCT2051190001 | 29/03/2019 | 01/04/2019 | 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) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | amyotrophic lateral sclerosis ALS | 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. 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. | Inoue Haruhisa | NULL | Recruiting | 20age | 79age | Both | 24 | Phase 1 | Japan |
| 4 | JPRN-UMIN000036295 | 2019/03/29 | 26/03/2019 | 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) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | 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. 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 University | Provider of the investigational product: Pfizer Japan Inc. | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 24 | Phase 1 | Japan |
| 5 | NCT04744532 (ClinicalTrials.gov) | March 19, 2019 | 9/1/2021 | iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study | Phase 1/2 Study of Bosutinib in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Bosutinib (Phase 1 part);Drug: Bosutinib (Phase 2 part) | Kyoto University | Tokushima University;Kitasato University;Tottori University;Nara Medical University;Toho University;Hiroshima University;Pfizer | Recruiting | 20 Years | 75 Years | All | 49 | Phase 1/Phase 2 | Japan |