Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775848
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-02-16
Brief Title:
Study to Evaluate the Efficacy and Safety of BBP-418 Ribitol in Patients With Limb Girdle Muscular Dystrophy 2I LGMD2I
Sponsor:
ML Bio Solutions Inc
Organization:
ML Bio Solutions Inc
Study Overview
Official Title:
A Phase 3 Randomized Placebo-controlled Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 Ribitol in Patients With Limb Girdle Muscular Dystrophy 2I LGMD2I
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fortify
Brief Summary:
This study will evaluate the safety and efficacy of long-term administration of BBP-418 in patients with LGMD2IR9 The study will include patients ages 12 to 60 consistent with the existing preclinical toxicology profile This will encompass the significant majority of existing diagnosed patients based upon the established epidemiology of the disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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