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Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Secondary endpoints revised (5)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label extension (rollover) study designed to evaluate the long-term safety and efficacy of BBP-418 (ribitol) in participants with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) who have previously participated in Study MLB-01-005 (Fortify). Participants will receive BBP-418 administered orally at protocol-defined doses and schedules. The study will assess long-term safety through monitoring of adverse events, clinical laboratory evaluations, and other safety assessments. Efficacy will be evaluated using functional measures and other clinical endpoints relevant to LGMD2I/R9. Participants will be followed for up to 36 months, with a final safety follow-up assessment conducted approximately 30 days after the last dose of study drug.
Trial Details
NCT Number NCT07678775
Lead Sponsor ML Bio Solutions, Inc.
Conditions
(from sponsor)		 Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
Related terms Muscular Dystrophy, Limb-Girdle, Type 2I
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov