Status:
ENROLLING_BY_INVITATION
An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)
Lead Sponsor:
Tisento Therapeutics
Conditions:
Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the long-term safety and tolerability of zagociguat in patients with MELAS who completed study medication treatment in the lead-in study TIS6463-203. TIS...
Detailed Description
On Screening Visit Day -1 (which corresponds to Period 2 Week 12 Visit from lead-in study TIS6463-203), participants will sign the informed consent form, be confirmed eligible for this open-label exte...
Eligibility Criteria
Inclusion
- Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF).
- Completed TIS6463-203 treatment through the Period 2 Week 12 Visit.
- Agrees to follow lifestyle restrictions.
- Other criteria per the protocol.
Exclusion
- 1\. Any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and/or completion of all trial requirements.
Key Trial Info
Start Date :
August 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06961344
Start Date
August 18 2025
End Date
July 1 2028
Last Update
December 29 2025
Active Locations (11)
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1
UC San Diego - Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92037
2
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
3
Rare Disease Research
Atlanta, Georgia, United States, 30329
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114