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
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the original study
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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.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Akron Children's Hospital
RECRUITINGAkron, Ohio, 44307, United States
Contact
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Azienda Ospedaliera Universitaria Gaetano Martino Messina
RECRUITINGMessina, 98125, Italy
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Azienda Ospedaliero Universitaria Pisana
RECRUITINGPisa, 56126, Italy
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Baylor College of Medicine (BCM)
RECRUITINGHouston, Texas, 77030, United States
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CHU de NICE - Hôpital Archet 2
RECRUITINGNice, France
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CIBERER- IDIBAPS, Faculty of Medicine, University of Barcelona
RECRUITINGBarcelona, Spain
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Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
RECRUITINGBordeaux, France
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Centre Hospitalier Universitaire d'Angers
RECRUITINGAngers, 49933, France
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Centre Hospitalier Universitaire de Nantes
NOT_YET_RECRUITINGNantes, 44093, France
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Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2
RECRUITINGNice, France
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Charite - Universitaetsmedizin Berlin
RECRUITINGBerlin, 10117, Germany
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Charles University and General University Hospital
NOT_YET_RECRUITINGPrague, 128 08, Czechia
Contact
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Children's Hospital Colorado - Center for Cancer and Blood Disorders (CCBD) - Anschutz Medical Campus Location
RECRUITINGAurora, Colorado, 80045, United States
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Columbia University Irving Medical Center
NOT_YET_RECRUITINGNew York, New York, 100032, United States
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Copenhagen Neuromuscular Center, Rigshospitalet
RECRUITINGCopenhagen, Denmark
Contact
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Department of Clinical Neurosciences, Addenbrooke's Hospital
RECRUITINGCambridge, United Kingdom
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Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITINGMilan, 20133, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
RECRUITINGRoma, 00168, Italy
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Groupe Hospitalier Pitie-Salpetriere
RECRUITINGParis, France
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Hopital Roger Salengro, CHRU de Lille
RECRUITINGLille, France
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Hopital Universitaire Necker Enfants Malades
NOT_YET_RECRUITINGParis, 75015, France
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Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel
RECRUITINGBrussels, Belgium
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Hopitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, 67091, France
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Hospital General Universitario de Catalunya
RECRUITINGBarcelona, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, Spain
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Hospital Universitario Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Hospital de la Santa Creu i Sant Pau
COMPLETEDBarcelona, Spain
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IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
RECRUITINGBologna, 40139, Italy
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IU Health University Hospital
NOT_YET_RECRUITINGIndianapolis, Indiana, 46202, United States
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Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITINGNew York, New York, 10029-6574, United States
Contact
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Johns Hopkins University School of Medicine
NOT_YET_RECRUITINGBaltimore, Maryland, 21205, United States
Contact
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Neurology and Neuromuscular Care Center-Neurology Rare Disease Center
NOT_YET_RECRUITINGFlower Mound, Texas, 75028, United States
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Neuroscience Research Australia
NOT_YET_RECRUITINGRandwick, New South Wales, 2031, Australia
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Novel Clinical Research Center, LLC
RECRUITINGMiami, Florida, 33186, United States
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Perron Institute
NOT_YET_RECRUITINGNedlands, Western Australia, 6009, Australia
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Radboud University Medical Center
RECRUITINGNijmegen, 6525, Netherlands
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Rare Disease Research, LLC
RECRUITINGAtlanta, Georgia, 303129, United States
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Royal Melbourne Hospital
NOT_YET_RECRUITINGParkville, Victoria, 3050, Australia
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Royal North Shore Hospital
NOT_YET_RECRUITINGSaint Leonards, New South Wales, 2065, Australia
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Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
RECRUITINGNewcastle, United Kingdom
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Tekton Marlboro Neurology
RECRUITINGMarlboro, New Jersey, 07746, United States
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The Children's Hospital of Philadelphia
NOT_YET_RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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The Regents of the University of California - San Diego
RECRUITINGSan Diego, California, 292093, United States
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States
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UCSF Movement Disorders Clinic
NOT_YET_RECRUITINGSan Francisco, California, 94158, United States
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UPMC Children's Hospital of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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Universitaetsklinikum Halle
RECRUITINGHalle, 6120, Germany
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Universitair Ziekenhuis Gent
RECRUITINGGhent, Belgium
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Universitair Ziekenhuis Leuven Gasthuisberg Campus
RECRUITINGLeuven, Belgium
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Universitat de Valencia
NOT_YET_RECRUITINGValencia, 46026, Spain
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University College London Hospitals Nhs Foundation Trust
RECRUITINGLondon, United Kingdom
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University of California, Irvine - ALS & Neuromuscular Center
RECRUITINGOrange, California, 92868, United States
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Washington University School of Medicine - Center for Advanced Medicine (CAM) - Neuroscience Center
NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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Yale University School of Medicine
NOT_YET_RECRUITINGNew Haven, Connecticut, 06519, United States
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