Zagociguat for MELAS Syndrome
(PRIZM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that current use of prohibited medication will be reviewed by the investigator. It's best to discuss your medications with the trial team.
What data supports the effectiveness of the drug Zagociguat for MELAS Syndrome?
Are You a Good Fit for This Trial?
This trial is for individuals with MELAS syndrome, a condition that affects many parts of the body, particularly the brain and nervous system. Participants must have genetic markers confirming their diagnosis. Specific details on who can't join are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either zagociguat or placebo once daily for 12 weeks
Washout
A 4-week washout period between treatment periods
Treatment Period 2
Participants receive the alternate treatment (zagociguat or placebo) once daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Zagociguat
Zagociguat is already approved in United States for the following indications:
- Mitochondrial disease (Orphan Drug designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tisento Therapeutics
Lead Sponsor