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NCT03759678 · ClinicalTrials.gov registry record · Phase 2

N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T)

A Phase 2 study of Ataxia-Telangiectasia and Louis Bar Syndrome, sponsored by IntraBio.

Active
Registry status
Phase 2
Development phase
39
Enrollment target
5
Study locations

NCT03759678 is a Phase 2 study of Ataxia-Telangiectasia and Louis Bar Syndrome that is active but no longer recruiting, run by IntraBio. The registered enrollment target is 39 participants. The trial reports 5 study locations across 4 states.

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The verdict

NCT03759678, a Phase 2 study of Ataxia-Telangiectasia and Louis Bar Syndrome, is active but no longer recruiting, sponsored by IntraBio.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
39 participants
Enrollment target
5
Study locations

Study Summary

This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of Ataxia-Telangiectasia (A-T). There are two phases to this study: the Parent Study, and the Extension Phase. The Parent Study evaluates the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the symptomatic treatment of A-T. The Extension Phase evaluates the long-term safety and efficacy of IB1001 for the neuroprotective, disease-modifying treatment of A-T.

Interventions

  • DRUG IB1001

Study Locations (5)

Other

  • University of Giessen - Giessen
  • Ludwig Maximilian University of Munich - München

California

  • University of California - Los Angeles - Los Angeles

Spain

  • Hospital Universitario La Paz - Madrid

Cambridgeshire

  • Royal Papworth Hospital NHS Foundation Trust - Cambridge

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2020-01-08
Est. Completion 2025-07-01
Phase Phase 2

Sponsor

IntraBio

6 total trials

What the Registry Record Tells You About NCT03759678

The ClinicalTrials.gov registry entry for NCT03759678 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 39 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 1 intervention - of which IB1001 is the first listed.

NCT03759678 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Spain.

Frequently Asked Questions

What is clinical trial NCT03759678 about?

NCT03759678 is a clinical study titled "N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T)". This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of Ataxia-Telangiectasia (A-T). There are two phases to this study: the Parent Study, and the Extension Phase. The P...

What is the current status of trial NCT03759678?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2020-01-08. Estimated completion is 2025-07-01.

What conditions does trial NCT03759678 study?

This clinical trial studies the following conditions: Ataxia-Telangiectasia, Louis Bar Syndrome.

What interventions are being tested in trial NCT03759678?

The interventions under investigation include: IB1001 (DRUG).

Who is sponsoring clinical trial NCT03759678?

This trial is sponsored by IntraBio, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03759678 being conducted?

This trial has 5 study locations across California, Spain, Cambridgeshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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