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

Study acronym: Fortify
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Jul 2027 → Sep 2027
See other at-risk trials from ML Bio Solutions, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 2027 to Sep 2027
    • Final enrollment: 112 participants (planned 81)
    • Site details revised at 1 of 21 sites
    v32
  2. Site details revised at 1 of 21 sitesv31
  3. Study sites: 22 to 21v30
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 24 to 22
    v29
  5. Study sites: 23 to 24v28
Show 26 earlier versionsHide 26 earlier versions
  1. Eligibility criteria expanded, about 19 words
    • Site details revised at 9 of 23 sites
    v27
  2. Site details revised at 1 of 23 sitesv26
  3. Site details revised at 1 of 23 sitesv25
  4. Site contacts updated at 1 of 23 sitesv24
  5. Site details revised at 1 of 23 sitesv23
  6. Site details revised at 3 of 23 sitesv22
  7. Site contacts updated at 1 of 23 sitesv21
  8. Site details revised at 2 of 23 sitesv20
  9. Site details revised at 1 of 23 sitesv19
  10. Site details revised at 4 of 23 sitesv18
  11. Study sites: 20 to 23v17
  12. Site details revised at 1 of 20 sitesv16
  13. Site details revised at 1 of 20 sitesv15
  14. Site details revised at 1 of 20 sitesv14
  15. Study sites revised (20)v13
  16. Site details revised at 2 of 20 sitesv12
  17. Study sites: 19 to 20v11
  18. Site details revised at 1 of 19 sitesv10
  19. Site details revised at 1 of 19 sitesv9
  20. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2023 to May 31, 2023
    • Site details revised at 19 of 19 sites
    v8
  21. Study sites: 12 to 19
    • Start date: Apr 2023 to May 2023
    v7
  22. Site contacts updated at 1 of 12 sitesv6
  23. Site contacts updated at 2 of 12 sitesv5
  24. Site contacts updated at 1 of 12 sitesv4
  25. Site contacts updated at 1 of 12 sitesv3
  26. Study sites: 1 to 12v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT05775848
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 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov