Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 20 study locations across 14 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06402123
The ClinicalTrials.gov registry entry for NCT06402123 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tisento Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.