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A Phase 2b Study of Zagociguat in Patients With MELAS
Sponsor: Tisento Therapeutics
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
zagociguat 15mg
Once-daily oral tablets
zagociguat 30mg
Once-daily oral tablets
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