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

> **NCT06961344** · PHASE2 · ENROLLING_BY_INVITATION · sponsor: **Tisento Therapeutics** · enrollment: 44 (estimated)

## Conditions studied

- Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)

## Interventions

- **DRUG:** zagociguat 15mg

## Key facts

- **NCT ID:** NCT06961344
- **Lead sponsor:** Tisento Therapeutics
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ENROLLING_BY_INVITATION
- **Start date:** 2025-08-18
- **Primary completion:** 2028-07
- **Final completion:** 2028-07
- **Target enrollment:** 44 (ESTIMATED)
- **Last updated:** 2026-05-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06961344

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06961344, "An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT06961344. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
