drugset / Trial / NCT06402123

A Phase 2b Study of Zagociguat in Patients With MELAS

NCT06402123 ↗

Phase 2 Completed 43 enrolled Tisento Therapeutics
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2024-09-10
Primary completion
2026-06-29
Completion
2026-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject zagociguat Small molecule 15 mg Oral
Subject zagociguat Small molecule 30 mg Oral

Indications