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Pivotal Study of N-acetyl-L-leucine for CACNA1A

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion moved earlier from Aug 1, 2028 to May 1, 2027
    • Study sites: 10 to 11
    v6
  2. Primary completion date: Aug 1, 2028 to May 1, 2027v5
  3. Primary completion pushed from Aug 1, 2027 to Aug 1, 2028
    • Recruitment opened
    • Start date: Sep 1, 2026 to Aug 17, 2026
    • Site details revised at 10 of 10 sites
    v4
  4. Trial sites expanded: 5 → 10 locationsv3
  5. Secondary endpoints: details revised at 1 of 4 entriesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
IntraBio Inc
4 trials monitored
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Migraine
482 trials monitored
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A pivotal, randomized, double-blind, placebo-controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of CACNA1A. The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care.
Trial Details
NCT Number NCT07221292
Lead Sponsor IntraBio Inc
Conditions
(from sponsor)		 CACNA1A, Spinocerebellar Ataxia Type 6, Episodic Ataxia Type 2, Familial Hemiplegic Migraine-1
Related terms Episodic Ataxia, Type 2, Spinocerebellar Ataxias
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov