Current Clinical Trial and Study Listings

Clinical Trial |A Phase 2b Study of Zagociguat in Patients With MELAS (PRIZM)

PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.

Enrolment: Recruiting now!
Sites: There are two trial site in Canada: Winnipeg and Hamilton

Inclusion Criteria:

1. Between the ages of 18 and 75 years of age
2. Diagnosed with MELAS based on presence of: 1) documented pathogenic variant in a mtDNA gene (2) History of one or more stroke-like episodes (SLEs) with MRI findings consistent with stroke-like lesions.
3. Scores below normal average on the iDSST and GMLT
4. Reports fatigue due to MELAS
5. Can complete at least 1 sit-to-stand in the 30-second test interval
6. Completes all at-home weekly activities independently during the screening period
7. Other criteria per the protocol

Exclusion Criteria:

1. Systolic blood pressure (BP) 90 mmHg or diastolic BP 60 mmHg.
2. Orthostatic hypotension when measured after standing from a semi-recumbent/supine position.
3. Active cancer significant enough to confound the results of this study.
4. Severe gastrointestinal dysmotility that may impact participation.
5. Recent history (within last 6 months) of platelet dysfunction, hemophilia, von Willebrand disease, coagulation disorder, other bleeding diathesis condition(s), or significant, nontraumatic bleeding episodes.
6. History of spontaneous fracture(s) that in the investigator’s opinion represents a safety risk for trial participation.
7. Current use of prohibited medication (reviewed by investigator).
8. Any medical or other condition that the investigator thinks would preclude study participation.
9. Other exclusion criteria per protocol

CONTACT:

For questions, please contact:

• Winnipeg – Maggie Wilson: (204) 787-1405 or Maggie.Wilson@umanitoba.ca
• Hamilton – Erin Hatcher: (905) 521-2100 ext. 76929 or hatchere@hhsc.ca
• MitoCanada – support@mitocanada.org

For more details on this clinical trial, visit ClinicalTrials.gov