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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 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. The trial reports 20 study locations across 3 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05650229
The ClinicalTrials.gov registry entry for NCT05650229 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abliva AB, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.
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