Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587908
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2020-10-13
Brief Title:
A Phase 3 Study of TAS-205 in Patients With Duchenne Muscular DystrophyREACH-DMD
Sponsor:
Taiho Pharmaceutical Co Ltd
Organization:
Taiho Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 3 Randomized Placebo-controlled Double-blind and Open-label Extension Study of TAS-205 in Patients With Duchenne Muscular Dystrophy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of TAS-205 in patients with Duchenne muscular dystrophy
Detailed Description:
Ambulatory Cohort The main purpose of this cohort is to assess the efficacy of TAS-205 in patients with Duchenne muscular dystrophy DMD compared with placebo as measured by the mean change from baseline to 52 weeks in the time to rise from the floor Following completion of the treatment period patients may elect to continue in open-label extension study
Non-ambulatory Cohort The main purpose of this cohort is to assess the safety of TAS-205 in patients with DMD by collecting the incidence of adverse events for 52 weeks
Non-ambulatory Cohort The main purpose of this cohort is to assess the safety of TAS-205 in patients with DMD by collecting the incidence of adverse events for 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None