Open Label Extension evaluating zagociguat in participants with MELAS
Research type
Research Study
Full title
An open-label extension study evaluating the safety of zagociguat in participants with MELAS who completed TIS6463-203
IRAS ID
1011067
Contact name
Wheatley Spence
Contact email
Sponsor organisation
Tisento Therapeutics, Inc.
Eudract number
2024-517514-15
Clinicaltrials.gov Identifier
Research summary
This study is an open label extension to allow participants from the TIS6463-203 study to continue taking zagociguat and assess its safety over a longer period. Zagociguat is being tested as a treatment for mitochondrial encephalomyopathy, lactic acidosis and strike-like episodes (MELAS) which can results in stroke like episodes, generalised fatigue . There is currently no approved treatment for MELAS. Participants will take a 15mg dose of zagociguat, daily, over a 104 week period. In-clinic visits will take place at 3 and 6 months following the first dose, with additional visits taking place at 6 month intervals; during these visits a number of assessments and questionnaires will be undertaken. Following the discontinuation of zagociguat, participants will have a follow up visit 4 weeks after.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0074
Date of REC Opinion
29 May 2025
REC opinion
Further Information Favourable Opinion