← Back to Search

Vasodilator

Zagociguat for MELAS Syndrome (PRIZM Trial)

Phase 2

Recruiting

Research Sponsored by Tisento Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of one or more stroke-like episodes (SLEs) with magnetic resonance imaging (MRI) findings consistent with stroke-like lesions

18 to 75 years of age

Must not have

Active cancer significant enough to confound the results of this study

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1 through washout for treatment period 1 and weeks 1 through follow-up for treatment period 2

Summary

"This trial is testing the effectiveness and safety of two different doses of an oral medication called zagociguat compared to a placebo in patients with a specific genetic condition called MELAS. Participants will take

Who is the study for?

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.

What is being tested?

The study tests zagociguat at two different doses (15mg and 30mg) against a placebo to see which is more effective in treating MELAS symptoms. It's a double-blind study, meaning neither participants nor researchers know who gets the real drug or placebo during the trial.

What are the potential side effects?

While specific side effects aren't listed here, typical clinical trials may observe issues like headaches, nausea, allergic reactions or other medication-related complications. The severity can range from mild to serious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had stroke-like episodes confirmed by MRI.

Select...

I am between 18 and 75 years old.

Select...

I have been diagnosed with MELAS due to a specific genetic change.

Select...

I experience fatigue because of my MELAS condition.

Select...

I can stand up from a chair at least once in 30 seconds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer is not affecting the study's outcomes.

Select...

I have not had bleeding disorders or unexplained bleeding in the last 6 months.

Select...

I have severe vision problems that prevent me from taking tests on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1 through washout for treatment period 1 and weeks 1 through follow-up for treatment period 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1 through washout for treatment period 1 and weeks 1 through follow-up for treatment period 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1 through washout for treatment period 1 and weeks 1 through follow-up for treatment period 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-emergend Adverse Events (TEAEs)

• PROMIS Fatigue MELAS Short Form scores • Memory composite scores (One Card Learning and One Back Tests) • International Digit Symbol Substitution Test scores

Secondary study objectives

Groton Maze Learning Test (GMLT) scores

Number of repetitions completed during the 30-second sit-to-stand test

PROMIS Cognitive Function MELAS Short Form (PCFM-SF) score

+1 more