A Phase 2b Study of Zagociguat in Patients With MELAS (NCT06402123) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2b Study of Zagociguat in Patients With MELAS
United States43 participantsStarted 2024-09-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Systolic blood pressure (BP) 90 mmHg or diastolic BP 60 mmHg.
✕. Orthostatic hypotension when measured after standing from a semi-recumbent/supine position.
✕. Active cancer significant enough to confound the results of this study.
✕. Severe gastrointestinal dysmotility that may impact participation.
✕. 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.
What they're measuring
1
• PROMIS Fatigue MELAS Short Form scores• Groton Maze Learning Test scores • International Digit Symbol Substitution Test scores
Timeframe: Weeks 9 through 12 of each treatment period
2
Incidence of Treatment-emergent Adverse Events (TEAEs)
Timeframe: Weeks 1 through washout for treatment period 1 and Weeks 1 through follow-up for treatment period 2