Phase 2Completed
A Phase 2b Study of Zagociguat in Patients With MELAS (PRIZM)
Phase 2b Randomized, Double-blind, Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of Zagociguat in Participants With MELAS (PRIZM)
- Sponsor
- Tisento Therapeutics (Industry)
- Enrolment
- 43 enrolled
- Conditions
- Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
- Interventions
- zagociguat 15mg; zagociguat 30mg; Placebo
- Ages
- adults, older adults
- Registry
- NCT06402123
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- • PROMIS Fatigue MELAS Short Form scores• Groton Maze Learning Test scores • International Digit Symbol Substitution Test scores
- Incidence of Treatment-emergent Adverse Events (TEAEs)
History
Last registry update
Primary completion
Started
Registered