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NCT05650229 · ClinicalTrials.gov registry record · Phase 2
Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease
A Phase 2 study of Primary Mitochondrial Disease, sponsored by Abliva AB.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT05650229: Recruiting Phase 2 study of Primary Mitochondrial Disease, sponsored by Abliva AB.
NCT05650229 is a Phase 2 study of Primary Mitochondrial Disease that is actively recruiting participants, run by Abliva AB. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05650229, a Phase 2 study of Primary Mitochondrial Disease, is actively recruiting participants, sponsored by Abliva AB.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily living as well as on functional lower extremity strength and endurance. Additionally, the study evaluates the safety and tolerability of KL1333.
Primary Outcome
Change in t-score. Higher scores indicate greater fatigue severity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG KL1333
Study Locations (20)
Other
- Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel - Brussels
- Universitair Ziekenhuis Gent - Ghent
- Universitair Ziekenhuis Leuven Gasthuisberg Campus - Leuven
- Copenhagen Neuromuscular Center, Rigshospitalet - Copenhagen
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin - Bordeaux
- Hopital Roger Salengro, CHRU de Lille - Lille
- Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2 - Nice
- CHU de NICE - Hôpital Archet 2 - Nice
- Groupe Hospitalier Pitie-Salpetriere - Paris
- IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna - Bologna
- Azienda Ospedaliera Universitaria Gaetano Martino Messina - Messina
- Fondazione IRCCS Istituto Neurologico Carlo Besta - Milan
- Azienda Ospedaliero Universitaria Pisana - Pisa
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore - Roma
- CIBERER- IDIBAPS, Faculty of Medicine, University of Barcelona - Barcelona
- Hospital de la Santa Creu i Sant Pau - Barcelona
- Hospital General Universitario de Catalunya - Barcelona
- Hospital Universitario 12 de Octubre - Madrid
Ohio
- Akron Children's Hospital - Akron
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
What NCT05650229 shows while recruiting
NCT05650229 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 1 condition, with Primary Mitochondrial Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05650229 names 20 study sites across 3 states, led by Other, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT05650229 about?
NCT05650229 is a clinical study titled "Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease". The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily...
What is the current status of trial NCT05650229?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2022-12-13. Estimated completion is 2027-11.
What conditions does trial NCT05650229 study?
This clinical trial studies the following conditions: Primary Mitochondrial Disease.
What interventions are being tested in trial NCT05650229?
The interventions under investigation include: Placebo (DRUG), KL1333 (DRUG).
Who is sponsoring clinical trial NCT05650229?
This trial is sponsored by Abliva AB, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05650229 being conducted?
This trial has 20 study locations across Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Mitochondrial Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05650229's enrollment target sits among peer trials
180 365th of 2000 higher than 1,611 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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