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A Phase 2b Study of Zagociguat in Patients With MELAS

(PRIZM)

Sponsored by Tisento Therapeutics

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Active, Not Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 3, 2026

Phase

Clinical Trial

Sponsor

Tisento Therapeutics

Enrollment Target

44

Start Date

Sep 2024

๐Ÿ“Š
1 of 44 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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

Inclusion Criteria

Signed consent form. 2. 18 to 75 years of age. 3. Diagnosed with MELAS based on the presence of each of the following criteria: 1. A documented pathogenic variant in a mitochondrial DNA (mtDNA) gene. 2. History of one or more stroke-like episodes (SLEs) with magnetic resonance imaging (MRI) findings consistent with stroke-like lesions. 4. Scores below normal average on the iDSST and GMLT. 5. Reports fatigue due to MELAS. 6. Can complete at least 1 sit-to-stand in the 30-second test interval. 7. Completes all at-home weekly activities independently during the Screening Period (caregiver may help set up device/app, log-in, etc.). 8. Other criteria per the protocol.

Exclusion Criteria

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 t

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

44 participants

๐ŸŽ‚

Age Range

18 Years - 75 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Tisento Therapeutics

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

La Jolla

California

Location available
View La Jolla location page
Unknown

Aurora

Colorado

Location available
View Aurora location page
Unknown

Atlanta

Georgia

Location available
View Atlanta location page
Unknown

Baltimore

Maryland

Location available
View Baltimore location page
Unknown

Boston

Massachusetts

Location available
View Boston location page
Unknown

New York

New York

Location available
View New York location page
Unknown

New York

New York

Location available
View New York location page
Unknown

Akron

Ohio

Location available
View Akron location page
Unknown

Philadelphia

Pennsylvania

Location available
View Philadelphia location page

๐Ÿ“ And 2 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

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Looking for MELAS Syndrome Treatment in La Jolla?

Join others in California exploring innovative treatment options through clinical research

MELAS Syndrome Treatment Options in La Jolla, California

If you're searching for MELAS Syndrome treatment in La Jolla, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in La Jolla, Aurora, Washington D.C. and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with MELAS Syndrome. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 44 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for MELAS Syndrome?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for MELAS Syndrome

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This MELAS Syndrome Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06402123. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.