New drug aims to ease fatigue in mitochondrial disease

NCT ID NCT05650229

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether KL1333 can reduce fatigue and improve leg strength in adults with primary mitochondrial disease, a genetic condition that affects energy production. About 180 participants will receive either KL1333 or a placebo twice daily for 48 weeks. The study measures changes in fatigue symptoms and physical function.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

KL1333

What this could lead to

If it works, this could point toward a treatment that reduces fatigue and improves daily function for people with primary mitochondrial disease.

What could go wrong

This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. It is also a placebo-controlled study, meaning some may not receive the active drug.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for PRIMARY MITOCHONDRIAL DISEASE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

diabetes mellitus mitochondrial disease muscle tissue disorder Muscle Weakness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Akron Children's Hospital

    RECRUITING

    Akron, Ohio, 44307, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Azienda Ospedaliera Universitaria Gaetano Martino Messina

    RECRUITING

    Messina, 98125, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Baylor College of Medicine (BCM)

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • CHU de NICE - Hôpital Archet 2

    RECRUITING

    Nice, France

    Contact

  • CIBERER- IDIBAPS, Faculty of Medicine, University of Barcelona

    RECRUITING

    Barcelona, Spain

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin

    RECRUITING

    Bordeaux, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Centre Hospitalier Universitaire d'Angers

    RECRUITING

    Angers, 49933, France

    Contact

    Contact Email: •••••@•••••

  • Centre Hospitalier Universitaire de Nantes

    NOT_YET_RECRUITING

    Nantes, 44093, France

    Contact

    Contact Email: •••••@•••••

  • Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2

    RECRUITING

    Nice, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Charite - Universitaetsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Charles University and General University Hospital

    NOT_YET_RECRUITING

    Prague, 128 08, Czechia

    Contact

    Contact Email: •••••@•••••

  • Children's Hospital Colorado - Center for Cancer and Blood Disorders (CCBD) - Anschutz Medical Campus Location

    RECRUITING

    Aurora, Colorado, 80045, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Columbia University Irving Medical Center

    NOT_YET_RECRUITING

    New York, New York, 100032, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Copenhagen Neuromuscular Center, Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Department of Clinical Neurosciences, Addenbrooke's Hospital

    RECRUITING

    Cambridge, United Kingdom

    Contact Email: •••••@•••••

    Contact

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, 20133, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    RECRUITING

    Roma, 00168, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Groupe Hospitalier Pitie-Salpetriere

    RECRUITING

    Paris, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hopital Roger Salengro, CHRU de Lille

    RECRUITING

    Lille, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hopital Universitaire Necker Enfants Malades

    NOT_YET_RECRUITING

    Paris, 75015, France

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel

    RECRUITING

    Brussels, Belgium

    Contact Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hopitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, 67091, France

    Contact Email: •••••@•••••

    Contact

  • Hospital General Universitario de Catalunya

    RECRUITING

    Barcelona, Spain

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

    Contact Email: •••••@•••••

    Contact

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Hospital de la Santa Creu i Sant Pau

    COMPLETED

    Barcelona, Spain

  • IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna

    RECRUITING

    Bologna, 40139, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • IU Health University Hospital

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Icahn School of Medicine at Mount Sinai

    NOT_YET_RECRUITING

    New York, New York, 10029-6574, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Johns Hopkins University School of Medicine

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21205, United States

    Contact

    Contact Email: •••••@•••••

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Neurology and Neuromuscular Care Center-Neurology Rare Disease Center

    NOT_YET_RECRUITING

    Flower Mound, Texas, 75028, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Neuroscience Research Australia

    NOT_YET_RECRUITING

    Randwick, New South Wales, 2031, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Novel Clinical Research Center, LLC

    RECRUITING

    Miami, Florida, 33186, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Perron Institute

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

    Contact

    Contact Email: •••••@•••••

  • Radboud University Medical Center

    RECRUITING

    Nijmegen, 6525, Netherlands

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Rare Disease Research, LLC

    RECRUITING

    Atlanta, Georgia, 303129, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Royal Melbourne Hospital

    NOT_YET_RECRUITING

    Parkville, Victoria, 3050, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Royal North Shore Hospital

    NOT_YET_RECRUITING

    Saint Leonards, New South Wales, 2065, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle, United Kingdom

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Tekton Marlboro Neurology

    RECRUITING

    Marlboro, New Jersey, 07746, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • The Children's Hospital of Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact

    Contact Email: •••••@•••••

  • The Regents of the University of California - San Diego

    RECRUITING

    San Diego, California, 292093, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

    Contact

    Contact Email: •••••@•••••

  • UCSF Movement Disorders Clinic

    NOT_YET_RECRUITING

    San Francisco, California, 94158, United States

    Contact

    Contact Email: •••••@•••••

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Universitaetsklinikum Halle

    RECRUITING

    Halle, 6120, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, Belgium

    Contact Email: •••••@•••••

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Universitair Ziekenhuis Leuven Gasthuisberg Campus

    RECRUITING

    Leuven, Belgium

    Contact Email: •••••@•••••

    Contact

  • Universitat de Valencia

    NOT_YET_RECRUITING

    Valencia, 46026, Spain

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University College London Hospitals Nhs Foundation Trust

    RECRUITING

    London, United Kingdom

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • University of California, Irvine - ALS & Neuromuscular Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Washington University School of Medicine - Center for Advanced Medicine (CAM) - Neuroscience Center

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Yale University School of Medicine

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06519, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.