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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 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. The trial reports 11 study locations across 4 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06673056
The ClinicalTrials.gov registry entry for NCT06673056 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IntraBio, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 4 distinct geographic areas - top geographies include 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.
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