Crossover study evaluating the efficacy and safety of zagociguat in participants with MELAS
Research type
Research Study
Full title
Phase 2b randomized, double-blind, placebo-controlled crossover study evaluating the efficacy and safety of zagociguat in participants with MELAS (PRIZM)
IRAS ID
1009861
Contact name
Wheatley Spence
Contact email
Sponsor organisation
Tisento Therapeutics, Inc.
Eudract number
2024-515389-15
Clinicaltrials.gov Identifier
Research summary
This research study evaluating the effects of zagociguat in participants with MELAS.
Fatigue (lack of energy) and cognitive issues (learning, thinking, reasoning, remembering, problem solving, decision making, paying attention, etc.) are common symptoms experienced by people with MELAS. Zagociguat works by stimulating an enzyme in the nitric oxide pathway that causes the formation of a molecule called cGMP. Increasing the production of cGMP may improve these symptoms of MELAS.
The purpose of this study is to assess the effects of zagociguat on fatigue and cognition, compared to a placebo. A placebo tablet looks like a zagociguat tablet but does not contain any active medicine. Because it is inactive, it should not cause any symptom improvements or side effects. Researchers use a placebo to see if a research medicine works better than and is as safe as not taking anything at all.REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0204
Date of REC Opinion
15 Aug 2024
REC opinion
Further Information Favourable Opinion