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A Phase 2b Study of Zagociguat in Patients with MELAS

Exploring Zagociguat for MELAS patients in a Phase 2b study.

Recruiting
18-75 years
All
Phase 2

MELAS is a condition affecting the brain and muscles, caused by changes in mitochondrial DNA. This study is testing a medicine called zagociguat to see if it helps people with MELAS feel less tired and think better. It’s called a Phase 2b study, which means it’s checking if the medicine works and if it's safe. The study is randomized, double-blind, and placebo-controlled, meaning neither the participants nor the doctors know who is getting the real medicine or a placebo (a fake pill). Participants will take the medicine or placebo for 12 weeks, then switch after a break. Visits happen at the clinic or possibly at home. You must be 18 to 75 years old and meet specific conditions to join. If you finish the study, you might get to try the real medicine in a later study.

  • Participate for about 28 weeks, including two 12-week treatment periods.
  • Clinic visits at start, middle, and end of each period, with some possible home visits.
  • Weekly assessments via phone app, plus extra check-ups during visits.
Study details
    Mitochondrial Encephalopathy
    Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)

NCT06402123

Tisento Therapeutics

15 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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