Clinical Trial

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

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-11-01; most recent amendment 2025-06-30.
Status change: Recruiting → Active, Not Recruiting 2025-06-30
Status change: Not Yet Recruiting → Recruiting 2025-04-01
Trial Details
NCT Number NCT06673056
Lead Sponsor IntraBio Inc
Conditions Ataxia-Telangiectasia, Ataxia-Telangiectasia (A-T)
Enrollment 60 participants
Start Date 2025-03-18
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-03