An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
Interventions
DRUG

zagociguat 15mg

once daily oral tablets

Trial Locations (7)

3052

Royal Melbourne Hospital, Melbourne

10029

Mount Sinai - Ichan School of Medicine, New York

44308

Akron Children's Hospital, Akron

77030

Baylor College of Medicine, Houston

80045

Children's Hospital of Colorado, Aurora

92037

UC San Diego - Altman Clinical and Translational Research Institute, La Jolla

02114

Massachusetts General Hospital, Boston

Sponsors
All Listed Sponsors
lead

Tisento Therapeutics

INDUSTRY

NCT06961344 - An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM) | Biotech Hunter | Biotech Hunter