Trial · NCT06402123
A Phase 2b Study of Zagociguat in Patients With MELAS
NCT06402123, Phase 2, Completed, Tisento Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2b Study of Zagociguat in Patients With MELAS. Trials, record NCT06402123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06402123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2b Study of Zagociguat in Patients With MELAS
- NCT number
- NCT06402123
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Tisento Therapeutics
- Conditions
- Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
- Interventions
- zagociguat 15mg, zagociguat 30mg, Placebo
- First posted
- 2024-05-07
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | • PROMIS Fatigue MELAS Short Form scores• Groton Maze Learning Test scores • International Digit Symbol Substitution Test scores | Weeks 9 through 12 of each treatment period | These measures are a patient reported questionnaire on MELAS-specific fatigue and 2 cognitive performance tests. These 3 outcome measures will be combined using a global statistical test. |
| Primary | Incidence of Treatment-emergent Adverse Events (TEAEs) | Weeks 1 through washout for treatment period 1 and Weeks 1 through follow-up for treatment period 2 | TEAEs are any untoward event that may or may not be related to study medication. |
| Secondary | Number of repetitions completed during the 30-second sit-to-stand test | Week 12 | Leg strength and exercise intolerance |
| Secondary | PROMIS Cognitive Function MELAS Short Form (PCFM-SF) score | Week 12 | Patient-reported questionnaire on MELAS-specific cognitive function |
| Secondary | Plasma concentrations of GDF-15 | Week 12 | Measure of disease pathophysiology |
| Secondary | Memory composite scores (One Card Learning and One Back Tests) for Week 9 through 12 | Week 9 through 12 | Test of memory |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Hidden Path Learning | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06402123
GET https://conductscience.org/api/trials/v1/NCT06402123/registered