Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)

Available (expanded access)

Conditions studied: Ataxia-Telangiectasia (A-T)

In brief

This expanded access program provides investigational levacetylleucine to patients with Ataxia-Telangiectasia who are not eligible for clinical trials and have no satisfactory alternative therapies.

Key facts

Study ID: NCT07380165
Run by: IntraBio Inc
Last updated by the study team: 2026-02-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient has a genetically confirmed diagnosis of Ataxia-Telangiectasia, a rare and serious disease with no alternative approved treatments.
Patient and/or their legal representative signed a written informed consent and, if applicable, written assent.
Patient weighs ≥15 kg.
If female and of reproductive potential, the treating physician verified the patient is not pregnant prior to enrollment and will use adequate contraceptive methods to avoid pregnancy during and up to 7 days after participating in the program.
Patient resides in the United States at time of enrollment and throughout the duration of their participation in the EAP.

You may not qualify if…

Patient is enrolled in or early withdrew participation from a clinical trial with levacetylleucine for A-T.
Patient is pregnant, breastfeeding, or considering pregnancy.
Patient has a physical, cognitive, psychiatric condition, or an active or suspected malignancy that, in the judgment of the treating physician, may pose a safety risk or interfere with the patient's ability to comply with the EAP procedures.
Patient is receiving N-acetyl-DL-leucine or N-acetyl-D-leucine and is unwilling to stop use throughout the duration of their participation in the EAP.
Patient is receiving another investigational drug for any reason.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.