Phase 2b Randomized, Double-blind, Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of Zagociguat in Participants With MELAS (PRIZM)
Status: Active_not_recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Signed consent form.
• 18 to 75 years of age.
• Diagnosed with MELAS based on the presence of each of the following criteria:
‣ A documented pathogenic variant in a mitochondrial DNA (mtDNA) gene.
⁃ History of one or more stroke-like episodes (SLEs) with magnetic resonance imaging (MRI) findings consistent with stroke-like lesions.
• Scores below normal average on the iDSST and GMLT.
• Reports fatigue due to MELAS.
• Can complete at least 1 sit-to-stand in the 30-second test interval.
• Completes all at-home weekly activities independently during the Screening Period (caregiver may help set up device/app, log-in, etc.).
• Other criteria per the protocol.
Locations
United States
California
UC San Diego - Altman Clinical and Translational Research Institute