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NCT06961344 · ClinicalTrials.gov registry record · Phase 2
An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)
A Phase 2 study, sponsored by Tisento Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT06961344 is a Phase 2 study that is active but no longer recruiting, run by Tisento Therapeutics. The registered enrollment target is 44 participants.
The verdict
NCT06961344, a Phase 2 study, is active but no longer recruiting, sponsored by Tisento Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
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.
Interventions
- DRUG zagociguat 15mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2025-08-18 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06961344
The ClinicalTrials.gov registry entry for NCT06961344 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tisento Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which zagociguat 15mg is the first listed.
NCT06961344 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06961344 about?
NCT06961344 is a clinical study titled "An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)". 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 st...
What is the current status of trial NCT06961344?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2025-08-18. Estimated completion is 2028-07.
What interventions are being tested in trial NCT06961344?
The interventions under investigation include: zagociguat 15mg (DRUG).
Who is sponsoring clinical trial NCT06961344?
This trial is sponsored by Tisento Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
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