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NCT07678775 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9
A Phase 3 study, sponsored by ML Bio Solutions.
- Active
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT07678775 is a Phase 3 study that is active but no longer recruiting, run by ML Bio Solutions. The registered enrollment target is 107 participants.
The verdict
NCT07678775, a Phase 3 study, is active but no longer recruiting, sponsored by ML Bio Solutions.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG BBP-418 (ribitol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2026-06-05 |
| Est. Completion | 2030-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07678775
The ClinicalTrials.gov registry entry for NCT07678775 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ML Bio Solutions, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BBP-418 (ribitol) is the first listed.
NCT07678775 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07678775 about?
NCT07678775 is a clinical study titled "Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9". 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 a...
What is the current status of trial NCT07678775?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2026-06-05. Estimated completion is 2030-10.
What interventions are being tested in trial NCT07678775?
The interventions under investigation include: BBP-418 (ribitol) (DRUG).
Who is sponsoring clinical trial NCT07678775?
This trial is sponsored by ML Bio Solutions, which has 4 total clinical trials registered on ClinicalTrials.gov.
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