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RECRUITING Phase 2

Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease

NCT05650229 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 180 participants
Start Date 2022-12-13
Est. Completion 2027-11
Phase Phase 2

Sponsor

Abliva AB

1 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05650229 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, Ohio, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05650229?

The interventions under investigation include: Placebo (DRUG), KL1333 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05650229?

This trial is sponsored by Abliva AB, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial