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NCT06673056 · ClinicalTrials.gov registry record · Phase 3
A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)
A Phase 3 study of Ataxia-Telangiectasia and Ataxia-Telangiectasia (A-T), sponsored by IntraBio.
- Active
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 11
- Study locations
NCT06673056: Active Phase 3 study of Ataxia-Telangiectasia and Ataxia-Telangiectasia (A-T), sponsored by IntraBio.
NCT06673056 is a Phase 3 study of Ataxia-Telangiectasia and Ataxia-Telangiectasia (A-T) that is active but no longer recruiting, run by IntraBio. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 11 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06673056, a Phase 3 study of Ataxia-Telangiectasia and Ataxia-Telangiectasia (A-T), is active but no longer recruiting, sponsored by IntraBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
The Scale for Assessment and Rating of Ataxia has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test. The range is 0-40 points, with a lower score representing neurological improvement and a higher score representing neurological worsening.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG N-Acetyl-L-Leucine
Study Locations (11)
Other
- University of Cologne - Cologne
- University of Giessen - Giessen
- Comenius University Bratislava - Bratislava
- University Hospital L. Pasteur - Košice
- Hospital Universitario La Paz - Madrid
- University of Bern - Bern
- Royal Papworth Hospital - Cambridge
- University of Nottingham - Nottingham
California
- University of California Los Angeles - Los Angeles
Massachusetts
- Massachusetts General Hospital - Boston
Texas
- The University of Texas Health (UT Health) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03-18 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 3 |
What the registry record for NCT06673056 still lists
NCT06673056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Ataxia-Telangiectasia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06673056 lists 11 locations in 4 states (Other, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06673056 about?
NCT06673056 is a clinical study titled "A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)". 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 ...
What is the current status of trial NCT06673056?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2025-03-18. Estimated completion is 2028-06-01.
What conditions does trial NCT06673056 study?
This clinical trial studies the following conditions: Ataxia-Telangiectasia, Ataxia-Telangiectasia (A-T).
What interventions are being tested in trial NCT06673056?
The interventions under investigation include: Placebo (OTHER), N-Acetyl-L-Leucine (DRUG).
Who is sponsoring clinical trial NCT06673056?
This trial is sponsored by IntraBio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06673056 being conducted?
This trial has 11 study locations across California, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06673056's enrollment target sits among peer trials
60 1805th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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