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ACTIVE NOT RECRUITING
NCT06402123
PHASE2

A Phase 2b Study of Zagociguat in Patients With MELAS

Sponsor: Tisento Therapeutics

View on ClinicalTrials.gov

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.

Official title: Phase 2b Randomized, Double-blind, Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of Zagociguat in Participants With MELAS (PRIZM)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2024-09-10

Completion Date

2026-06-20

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

zagociguat 15mg

Once-daily oral tablets

DRUG

zagociguat 30mg

Once-daily oral tablets

DRUG

Placebo

Once-daily oral tablets

Locations (20)

UC San Diego - Altman Clinical and Translational Research Institute

La Jolla, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

Rare Disease Research

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States

Mount Sinai - Ichan School of Medicine

New York, New York, United States

Akron Children's Hospital

Akron, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

University of Texas Medical School at Houston

Houston, Texas, United States

Neuroscience Research Australia

Sydney, New South Wales, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Shared Health/University of Manitoba

Winnipeg, Manitoba, Canada

McMaster University Medical Center

Hamilton, Ontario, Canada

University Hospital Bonn

Bonn, Germany

Ludwig-Maximilians-University of Munich

Munich, Germany

Neurologic Institute Carlo Besta of Milan

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

UCL Queen Square Institute of Neurology

London, United Kingdom

Newcastle University

Newcastle upon Tyne, United Kingdom