Home/Rare Diseases/Ataxia-Telangiectasia

Neurological & Neuromuscular

Ataxia-Telangiectasia (A-T) Clinical Trials and Treatments

Also called A-T, Louis-Bar Syndrome, ATM Deficiency

The ATM gene makes a protein that acts as a sensor for broken DNA. When a strand breaks, ATM activates the machinery that repairs it and pauses cell division until the repair is done.

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About Ataxia-Telangiectasia

The ATM gene makes a protein that acts as a sensor for broken DNA. When a strand breaks, ATM activates the machinery that repairs it and pauses cell division until the repair is done. Without it, damage accumulates. The cells that suffer most are the Purkinje cells of the cerebellum, the part of the brain that coordinates movement, and they die off progressively through childhood. That is the ataxia: gait, balance, speech, eye movements and hand control all deteriorate as the cerebellum shrinks, even though muscle strength itself is preserved for a long time.

The same defect explains everything else about the disease. Immune cells that need to rearrange their own DNA to make antibodies do it poorly, so most people with A-T have low antibody levels and get repeated respiratory infections, which are the leading cause of death. Because damaged DNA is not repaired, the risk of cancer, above all leukemia and lymphoma, is many times higher than in the general population, and the same fragility makes patients dangerously sensitive to radiation, including standard X-ray doses and some chemotherapy. Blood levels of alpha-fetoprotein are raised in nearly everyone with A-T, which makes it a useful screening test when a child's unsteadiness has no obvious explanation. Genetic testing of ATM confirms the diagnosis.

Common Symptoms of Ataxia-Telangiectasia

Recognizing the signs of Ataxia-Telangiectasia early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Unsteady walking and poor balance appearing before age 5, after a normal start
  • Slurred speech and difficulty moving the eyes from side to side (oculomotor apraxia)
  • Involuntary jerking movements and tremor that worsen over time
  • Tiny dilated blood vessels (telangiectasias) on the whites of the eyes and skin, usually by age 5 to 8
  • Frequent sinus and lung infections from a weakened immune system
  • Difficulty swallowing and slowed growth in later childhood

Who Ataxia-Telangiectasia Affects

A-T is autosomal recessive: both parents carry one non-working copy of ATM without symptoms, and each pregnancy has a 1 in 4 chance of an affected child. It affects boys and girls equally and every ethnic group. Toddlers usually walk on time and then begin to wobble, and the diagnosis often takes years because early A-T looks like cerebral palsy. Most children need a wheelchair by around age 10. Life expectancy varies widely and has lengthened with better infection and cancer care, but most people with A-T live into early adulthood rather than beyond it.

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FDA-Approved Treatments for Ataxia-Telangiectasia

There is currently 1 FDA-approved medication for Ataxia-Telangiectasia. These therapies represent the current standard of care and may be used alongside or compared against investigational treatments in active clinical trials.

levacetylleucine
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

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Side Effect Explorer

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Genetic Testing

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted Ataxia-Telangiectasia Resources

Reputable organizations and medical references for learning more about Ataxia-Telangiectasia, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Ataxia-Telangiectasia

Use this Ataxia-Telangiectasia clinical trial finder to see the 8 studies recruiting patients and 2 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for neurological & neuromuscular conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

TrialsSite mapPipeline timeline

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

10 active trials worldwide
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RECRUITINGPHASE1, PHASE2Recently updatedNCT05691491

Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness

Intervention: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Temozolomide, Tuvusertib

Sponsor: National Cancer Institute (NCI)

This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue...

Ages 18 Years+23 locations
Started Sep 2023Updated 2 months agoEst. Mar 2027 (~5 months)
RECRUITINGPHASE1, PHASE2Recently updatedNCT04657068

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Intervention: ART0380, Gemcitabine, Irinotecan

Sponsor: Artios Pharma Ltd

This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:

Ages 18 Years+82 locations
Started Jan 2021Updated 2 months agoEst. Jan 2028 (~1y 4m)
NOT YET RECRUITINGRecently updatedNCT07709728

Biomarkers for Babies and Young Children With Ataxia Telangiectasia

Sponsor: University of Nottingham

The goal of this observational study is to identify progressive changes of quantitative brain and lung imaging, serum and movement-related biomarkers reflecting disease progression in pre-symptomatic infants and very young children (0-5 yo) with a genetic diagnosis of A-T, that c...

Ages 0 Years – 5 Years
Started Sep 2026Updated 2 months agoEst. Aug 2029 (~2y 11m)
RECRUITINGPHASE1, PHASE2Updated a few months agoNCT07215416

Safety and Efficacy of Mutation-targeted Precision Genetic Therapy for Ataxia-Telangiectasia (A-T)

Intervention: Antisense oligonucleotide targeting the ATM gene

Sponsor: Timothy Yu

This project aims to evaluate the safety and efficacy of precision genetic therapy for patients with Ataxia-telangiectasia (A-T), a rare neurodegenerative disease caused by mutations in the ATM gene. 7865C>T variant. The aim of this study is to delay or forestall progression of n...

Ages 0 Years – 17 Years1 location
Started Aug 2026Updated 4 months agoEst. Dec 2032 (~6y 3m)
RECRUITINGPHASE2Updated a few months agoNCT05010031

A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change

Intervention: Palliative radiotherapy

Sponsor: Memorial Sloan Kettering Cancer Center

This study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.

Ages 18 Years+7 locations
Started Aug 2021Updated 4 months agoEst. Aug 2027 (~11 months)
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Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Related Neurological & Neuromuscular Conditions

Other rare diseases in the neurological & neuromuscular category. Patients with Ataxia-Telangiectasia may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Ataxia-Telangiectasia News and Analysis

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Companies Developing Ataxia-Telangiectasia Treatments

1 pharmaceutical company has Ataxia-Telangiectasia in their rare disease portfolio

Frequently Asked Questions About Ataxia-Telangiectasia