Trial · NCT04475549
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
NCT04475549, Phase 2, Terminated, Tisento Therapeutics; results first posted 2023-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS). Trials, record NCT04475549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04475549
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
- NCT number
- NCT04475549
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Tisento Therapeutics
- Conditions
- MELAS
- Interventions
- IW-6463 Tablets
- First posted
- 2020-07-17
- Last updated
- 2024-08-29
- Results first posted
- 2023-11-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Study Drug Dose Reductions or Discontinuations Due to ≥ 1 Treatment Emergent Adverse Event (TEAE) | From first dose date to Day 43 (±4) | A TEAE is defined as an adverse event (AE) with an onset that occurs between the first dose of study drug and the end of study period. AEs are defined as an untoward medical occurrence that does not necessarily have a causal relationship with study drug treatment. |
| Primary | Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | From first dose date to Day 43 (±4) | AEs are defined as an untoward medical occurrence that does not necessarily have a causal relationship with study drug treatment. A TEAE is defined as an AE with an onset that occurs from the first dose of study drug up until the end of study period. An SAE is an AE that fulfills 1 or more of the following: results in death; is immediately life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent 1 of the outcomes listed above. Events were categorized as mild, moderate, or severe and as related or unrelated to study drug. AESIs include bleeding events, symptomatic hypotensive events and/or tachycardia, dizziness, syncope, and TEAEs related to change of neurobehaviors (ie, suicidality or euphoria). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Study Drug Dose Reductions or Discontinuations Due to ≥ 1 Treatment Emergent Adverse Event (TEAE) | From first dose date to Day 43 (±4) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | From first dose date to Day 43 (±4) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Study Drug Dose Reductions or Discontinuations Due to ≥ 1 Treatment Emergent Adverse Event (TEAE) | IW-6463 | Dose reduction due to TEAE | 1 | Participants | |
| Number of Participants With Study Drug Dose Reductions or Discontinuations Due to ≥ 1 Treatment Emergent Adverse Event (TEAE) | IW-6463 | Study drug discontinuation due to TEAE | 0 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any AE | 8 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any pretreatment AE | 1 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any TEAE | 8 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any severe TEAE | 0 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any study drug-related TEAE | 4 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any SAE | 0 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any TEAE leading to study drug discontinuation | 0 | Participants | |
| Number of Participants Who Experienced ≥1 AE, TEAE, Serious AE (SAE), or TEAE of Special Interest (AESI) | IW-6463 | Any TEAE leading to death | 0 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IW-6463 | 8 | |
| Overall Study | COMPLETED | IW-6463 | 8 | |
| Overall Study | NOT COMPLETED | IW-6463 | 0 |
Source ClinicalTrials.gov
Adverse events37
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cerebrovascular accident | Nervous system disorders | IW-6463 | 1 | 8 | |
| other | Disturbance in attention | Nervous system disorders | IW-6463 | 1 | 8 | |
| other | Dizziness | Nervous system disorders | IW-6463 | 1 | 8 | |
| other | Dysarthria | Nervous system disorders | IW-6463 | 1 | 8 | |
| other | Headache | Nervous system disorders | IW-6463 | 3 | 8 | |
| other | Hypoaesthesia | Nervous system disorders | IW-6463 | 1 | 8 | |
| other | Abdominal pain upper | Gastrointestinal disorders | IW-6463 | 1 | 8 | |
| other | Constipation | Gastrointestinal disorders | IW-6463 | 1 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | IW-6463 | 1 | 8 | |
| other | Dyspepsia | Gastrointestinal disorders | IW-6463 | 1 | 8 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IW-6463 | 0 | 8 |
| Total, other adverse events | IW-6463 | 8 | 8 |
| Total, serious adverse events | IW-6463 | 0 | 8 |
Source ClinicalTrials.gov
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT04475549
GET https://conductscience.org/api/trials/v1/NCT04475549/events?page=2