An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)

ID#: NCT06961344

Age: Birth - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Enrolling by invitation

Start Date: August 18, 2025

End Date: July 01, 2028

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. TIS6463-204 is evaluating zagociguat in an open-label extension study at the daily dose of 15mg. The study medication is a once daily oral table and will be provided at the clinic and/or shipped to the participant's home. Study assessments will be conducted during clinic visits which will occur at three months and then at six months. Thereafter, clinic visits will occur every six months.
Eligibility:

Inclusion Criteria:

1. Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF).

2. Completed TIS6463-203 treatment through the Period 2 Week 12 Visit.

3. Agrees to follow lifestyle restrictions.

4. Other criteria per the protocol.

Exclusion Criteria:

1. Any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and/or completion of all trial requirements.
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