A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T) (NCT06673056) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)
United States, Germany60 participantsStarted 2025-03-18
Plain-language 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.
Who can participate
Age range4 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. intrauterine device (IUD);
✓. surgical sterilization of the partner (vasectomy for 6 months minimum);
✓. combined (estrogen or progestogen containing) hormonal contraception associated with the inhibition of ovulation (either oral, intravaginal, or transdermal);
✓. progestogen only hormonal contraception associated with the inhibition of ovulation (either oral, injectable, or implantable);
✓. intrauterine hormone releasing system (IUS);
✓. bilateral tubal occlusion. 4. Females of non-childbearing potential who have undergone one of the following sterilization procedures at least 6 months prior to the first dose:
✓. hysteroscopic sterilization;
✓. bilateral salpingectomy;
Exclusion criteria
✕. Acetyl-Leucine (DL-, L-, D-) or derivatives.
✕. Excipients the IB1001 sachet (namely isomalt, hypromellose, and strawberry flavor).