Clinical Trial: Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

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)

Brief Summary: This study will evaluate the safety and efficacy of long-term administration of BBP-418 in patients with LGMD2I/R9.
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 Summary:
Sponsor: ML Bio Solutions, Inc.

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ML Bio Solutions, Inc.

Dates:
Date Received: February 16, 2023
Date Started: May 31, 2023
Date Completion: May 31, 2023
Last Updated: October 17, 2023
Last Verified: March 01, 2023