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Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease

NCT05650229 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-15

No results posted yet for this 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

  • Primary Mitochondrial Disease

Interventions

DRUG

KL1333

Twice daily

DRUG

Placebo

Twice daily

Sponsors & Collaborators

  • Abliva AB

    lead INDUSTRY

Principal Investigators

  • Amel Karaa, MD · Massachusetts General Hospital

  • Grainne Gorman, MD, PhD · Wellcome Centre for Mitochondrial Research, Newcastle University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2027-10-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05650229 on ClinicalTrials.gov