Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease
Public ClinicalTrials.gov record NCT05650229. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose, Adaptive Study of the Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05650229
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2022
- Primary completion
- Sep 30, 2027
- Completion
- Oct 31, 2027
- Last update posted
- Jun 25, 2026
2022 – 2027
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine - ALS & Neuromuscular Center | Orange | California | 92868 | Recruiting |
| The Regents of the University of California - San Diego | San Diego | California | 292093 | Recruiting |
| UCSF Movement Disorders Clinic | San Francisco | California | 94158 | Not yet recruiting |
| Children's Hospital Colorado - Center for Cancer and Blood Disorders (CCBD) - Anschutz Medical Campus Location | Aurora | Colorado | 80045 | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | Not yet recruiting |
| Novel Clinical Research Center, LLC | Miami | Florida | 33186 | Recruiting |
| Rare Disease Research, LLC | Atlanta | Georgia | 303129 | Recruiting |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | Not yet recruiting |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | Not yet recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Washington University School of Medicine - Center for Advanced Medicine (CAM) - Neuroscience Center | St Louis | Missouri | 63110 | Not yet recruiting |
| Tekton Marlboro Neurology | Marlboro | New Jersey | 07746 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 100032 | Not yet recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6574 | Not yet recruiting |
| Akron Children's Hospital | Akron | Ohio | 44307 | Recruiting |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Neurology and Neuromuscular Care Center-Neurology Rare Disease Center | Flower Mound | Texas | 75028 | Not yet recruiting |
| Baylor College of Medicine (BCM) | Houston | Texas | 77030 | Recruiting |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05650229, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05650229 live on ClinicalTrials.gov.