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Study of BBP-418 in Patients With LGMD2I

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. 4 versions Re-verified since Apr 24, 2023, no change to tracked fieldsv4-v7
  2. Primary completion date: Oct 1, 2023 to Nov 1, 2026v3 Show 6 more changesShow less
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 16 to confirmed 14
    • Study completion date: Aug 1, 2026 to Nov 1, 2026
    • Secondary endpoints: details revised at 4 of 4 entries
    • Eligibility criteria shortened, about 4 words
    • Study title shortened, about 4 words
  3. Primary completion date: Aug 5, 2021 to Oct 1, 2023v2 Show 6 more changesShow less
    • Enrollment target: 12 to 16
    • Study completion date: Aug 5, 2021 to Aug 1, 2026
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 8 words
    • Study title expanded, about 6 words
    • Eligibility criteria shortened, about 2 words
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
BBP-418 is being developed for the treatment of patients with Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I). This is an open label study to determine the safety and tolerability of ascending dose levels of BBP-418 in the treatment of ambulatory and non-ambulatory patients with LGMD2I for which no approved therapy currently exists.
Trial Details
NCT Number NCT04800874
Lead Sponsor ML Bio Solutions, Inc.
Conditions
(from sponsor)		 LGMD2I
Related terms Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Limb-Girdle, Type 2I
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov