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A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 11 of 11 sites
    v5
  2. Minor Site details revised at 9 of 11 sitesv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 9 to 11
    • Start date changed from estimate of Mar 1, 2025 to Mar 18, 2025
    v3
  4. Minor Study sites: 8 to 9
    • Secondary endpoints: 4 to 5
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A pivotal, randomized, double-blind, placebo-controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of Ataxia-Telangiectasia (A-T). 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 NCT06673056
Lead Sponsor IntraBio Inc
Conditions
(from sponsor)
Ataxia-Telangiectasia, Ataxia-Telangiectasia (A-T)
Related terms Ataxia Telangiectasia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov