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

Condition(s) studied

Investigational drug(s) / intervention(s)

zagociguat 15mg: once daily oral tablets

Study 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

Primary outcome measure(s)

• Incidence of Treatment-emergent Adverse Events (TEAEs) — Day 1 through the Follow-up for treatment period 4 weeks after last dose of study medication.
  TEAEs are any untoward event that may or may not be related to study medication.

Trial sites (16)