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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: Active Phase 2 study, sponsored by Tisento Therapeutics.
NCT06961344 is a Phase 2 study that is active but no longer recruiting, run by Tisento Therapeutics. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
TEAEs are any untoward event that may or may not be related to study medication.
Interventions
- DRUG zagociguat 15mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2025-08-18 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
What the registry record for NCT06961344 still lists
NCT06961344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which zagociguat 15mg is the first listed.
NCT06961344 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06961344's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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