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An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)
Sponsor: Tisento Therapeutics
Summary
The goal of this clinical trial is to evaluate the long-term safety and tolerability of zagociguat in patients with MELAS who completed study medication treatment in the lead-in study TIS6463-203. TIS6463-204 is evaluating zagociguat in an open-label extension study at the daily dose of 15mg. The study medication is a once daily oral table and will be provided at the clinic and/or shipped to the participant's home. Study assessments will be conducted during clinic visits which will occur at three months and then at six months. Thereafter, clinic visits will occur every six months.
Official title: An Open-label Extension Study Evaluating the Safety of Zagociguat in Participants With MELAS Who Completed TIS6463-203
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-08-18
Completion Date
2028-07
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
zagociguat 15mg
once daily oral tablets
Locations (15)
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
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
UT Health Houston
Houston, Texas, United States
Neuroscience Research Australia
Sydney, New South Wales, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
LMU Klinikum, Friedrich-Baur-Institute, Department of Neurology
Munich, Germany
Neurologic Institute Carlo Besta of Milan
Milan, Italy
University College London Hospital. The National Hospital for Neurology and Neurosurgery, Centre for Neuromuscular Diseases
London, United Kingdom
The Newcastle upon Tyne NHS Foundation Trust
Newcastle upon Tyne, United Kingdom