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Metabolic & Lysosomal

Leigh Syndrome Clinical Trials and Treatments

Also called Leigh syndrome, Leigh disease, Subacute necrotizing encephalomyelopathy, Leigh syndrome spectrum, MT-ATP6 Leigh syndrome, SURF1 deficiency, Mitochondrial Leigh syndrome

Mitochondria turn food and oxygen into the energy every cell runs on, and the brain uses more of it than any other organ. In Leigh syndrome a genetic fault in one of the energy-making steps, most often complex I or complex IV of the respiratory chain, or the pyruvate dehydrogenase enzyme, leaves nerve cells in the basal ganglia and brainstem starved of energy.

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About Leigh Syndrome

Mitochondria turn food and oxygen into the energy every cell runs on, and the brain uses more of it than any other organ. In Leigh syndrome a genetic fault in one of the energy-making steps, most often complex I or complex IV of the respiratory chain, or the pyruvate dehydrogenase enzyme, leaves nerve cells in the basal ganglia and brainstem starved of energy. Those regions control movement, swallowing, eye movement and breathing, which is why the disease looks the way it does. On a brain MRI the damage shows up as matching bright spots on both sides of those structures, and lactate is often raised in the blood or spinal fluid, especially during an illness.

The course is usually stepwise rather than steady. A child does well for a stretch, then an infection or fever triggers a sudden decline, followed by partial recovery to a new, lower baseline. Most children have at least one of these sudden declines, which may require hospitalization, and up to half die before age 3, most often from breathing or heart failure. Some children have stable periods lasting years, and outcomes vary widely: very early onset, brainstem involvement, the MT-ATP6 m.8993T>G change and MT-ND5 changes have been linked to more severe disease, published reports on SURF1 conflict, and a small number of subtypes, such as the thiamine transporter gene SLC19A3, respond to high-dose vitamins if caught early.

Diagnosis today rests on genetic testing, usually a nuclear gene panel or whole-exome sequencing plus mitochondrial DNA sequencing that measures the mutant load, rather than the muscle biopsy or autopsy that defined the disease for decades. Care is supportive: nutrition (often by feeding tube), seizure control, avoiding the drug valproate and other metabolic stressors, and a vitamin and cofactor mix that many specialists prescribe despite limited trial evidence.

Common Symptoms of Leigh Syndrome

Recognizing the signs of Leigh Syndrome 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.

  • Vomiting, diarrhea, trouble swallowing and poor weight gain, often the first signs
  • Loss of skills a child had already learned, with floppy muscle tone
  • Stiff or twisting postures (dystonia), unsteady balance and tremor
  • Irregular breathing, with pauses or unusually fast or slow breaths, from damage to the brainstem
  • Weak eye muscles, jerky eye movements and vision loss from optic nerve damage
  • Seizures, and in some children a thickened heart muscle, hearing loss, or liver or kidney problems

Who Leigh Syndrome Affects

Symptoms usually begin in the first year of life, often appearing or sharply worsening during a fever or infection. More than 130 genes can cause it (over 120 in the nuclear DNA and 15 in the mitochondrial DNA): about 70% to 80% of cases come from nuclear genes, usually inherited from both parents (autosomal recessive, a 1 in 4 chance in each pregnancy), and roughly 20% to 30% from mitochondrial DNA, which is inherited only through the mother, though some changes arise new in the child. In mitochondrial DNA cases, the share of mutated copies (heteroplasmy) can influence severity, most clearly for the MT-ATP6 m.8993 changes. A few genes, such as PDHA1, are X-linked. A minority of people first develop symptoms as teenagers or adults, with ataxia, nerve damage or psychiatric symptoms.

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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 Leigh Syndrome Resources

Reputable organizations and medical references for learning more about Leigh Syndrome, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Leigh Syndrome

Use this Leigh Syndrome clinical trial finder to see the 6 studies recruiting patients and 1 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for metabolic & lysosomal 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.

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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.

7 active trials worldwide
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RECRUITINGRecently updatedNCT01780168

The NIH MINI Study: Metabolism, Infection, and Immunity in Inborn Errors of Metabolism

Sponsor: National Human Genome Research Institute (NHGRI)

The Metabolism, Infection and Immunity (MINI) Study is a longitudinal natural history study at the National Institutes of Health (NIH) that aims to define the relationship between infection, immunity and clinical decline in individuals with mitochondrial disease. Mitochondrial di...

Ages 4 Weeks – 115 Years1 location
Started Dec 2012Updated todayEst. Dec 2099 (~73y 3m)
RECRUITINGRecently updatedNCT05554835

Global Registry and Natural History Study for Mitochondrial Disorders

Sponsor: LMU Klinikum

The main goal of the project is provision of a global registry for mitochondrial disorders to harmonize previous national registries, enable world-wide participation and facilitate natural history studies, definition of outcome measures and conduction of clinical trials.

Ages not specified34 locations
Started Feb 2009Updated 1 month agoEst. Dec 2040 (~14y 3m)
NOT YET RECRUITINGPHASE2Recently updatedNCT06990984

A Dose-ranging Study of TTI-0102 in Adults and Children With Leigh Syndrome Spectrum (LSS)

Intervention: TTI-0102: cysteamine-pantetheine disulfide, D-Mannitol

Sponsor: Thiogenesis Therapeutics, Inc.

The goal of this clinical trial is to investigate oral TTI-0102 to evaluate its pharmacokinetics, safety, and preliminary efficacy in patients with Leigh syndrome spectrum, in three sequences. First sequence will be placebo-controlled and include 12 adolescents and adults weighin...

Ages 5 Years – 55 Years
Started Oct 2026Updated 2 months agoEst. Jun 2027 (~9 months)
RECRUITINGNo updates in a whileNCT01694940

North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)

Sponsor: Columbia University

The North American Mitochondrial Disease Consortium (NAMDC) maintains a patient contact registry and tissue biorepository for patients with mitochondrial disorders.

Ages not specified17 locations
Started Jan 2011Updated 7 months agoEst. Dec 2026 (~3 months)
RECRUITINGHasn't posted an update in over a yearNCT01793168

Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

Sponsor: Sanford Health

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily a...

Ages not specified2 locations
Started Jul 2010Updated 1 year agoEst. Dec 2100 (~74y 3m)
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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 Metabolic & Lysosomal Conditions

Other rare diseases in the metabolic & lysosomal category. Patients with Leigh Syndrome may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Companies Developing Leigh Syndrome Treatments

3 pharmaceutical companies have Leigh Syndrome in their rare disease portfolio

Frequently Asked Questions About Leigh Syndrome