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NCT06402123 · ClinicalTrials.gov registry record · Phase 2
A Phase 2b Study of Zagociguat in Patients With MELAS
A Phase 2 study of Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome), sponsored by Tisento Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 20
- Study locations
NCT06402123: Active Phase 2 study of Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome), sponsored by Tisento Therapeutics.
NCT06402123 is a Phase 2 study of Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome) that is active but no longer recruiting, run by Tisento Therapeutics. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06402123, a Phase 2 study of Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome), is active but no longer recruiting, sponsored by Tisento Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 20
- Study locations
Study Summary
PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.
Primary Outcome
These measures are a patient reported questionnaire on MELAS-specific fatigue and 2 cognitive performance tests. These 3 outcome measures will be combined using a global statistical test.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG zagociguat 15mg
- DRUG zagociguat 30mg
Study Locations (20)
Other
- University Hospital Bonn - Bonn
- Ludwig-Maximilians-University of Munich - Munich
- Neurologic Institute Carlo Besta of Milan - Milan
- Fondazione Policlinico Universitario Agostino Gemelli - Roma
- UCL Queen Square Institute of Neurology - London
New York
- Columbia University Irving Medical Center - New York
- Mount Sinai - Ichan School of Medicine - New York
Texas
- Baylor College of Medicine - Houston
- University of Texas Medical School at Houston - Houston
California
- UC San Diego - Altman Clinical and Translational Research Institute - La Jolla
Colorado
- Children's Hospital of Colorado - Aurora
Georgia
- Rare Disease Research - Atlanta
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2026-06-20 |
| Phase | Phase 2 |
What the registry record for NCT06402123 still lists
NCT06402123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06402123 names 20 study sites across 14 states, led by Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT06402123 about?
NCT06402123 is a clinical study titled "A Phase 2b Study of Zagociguat in Patients With MELAS". PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.
What is the current status of trial NCT06402123?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2024-09-10. Estimated completion is 2026-06-20.
What conditions does trial NCT06402123 study?
This clinical trial studies the following conditions: Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome).
What interventions are being tested in trial NCT06402123?
The interventions under investigation include: Placebo (DRUG), zagociguat 15mg (DRUG), zagociguat 30mg (DRUG).
Who is sponsoring clinical trial NCT06402123?
This trial is sponsored by Tisento Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06402123 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06402123's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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