- Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9 — Active Not Recruiting • Phase III • NCT07678775.
- Long-term safety and effectiveness study of oral ribitol for a rare inherited muscle weakness condition in previous trial participants.
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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…