Trial · NCT07887412
Efficacy and Safety of Modafinil to Treat Fatigue in People With Mitochondrial Disease.
NCT07887412, Phase 3, Not yet recruiting, Kenneth Myers, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Modafinil to Treat Fatigue in People With Mitochondrial Disease. Trials, record NCT07887412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887412
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Modafinil to Treat Fatigue in People With Mitochondrial Disease.
- NCT number
- NCT07887412
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 15 participants, estimated
- Lead sponsor
- Kenneth Myers, MD
- Conditions
- Mitochondrial Disease
- Interventions
- Modafinil (M), Placebo
- First posted
- 2026-10-21
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-Minute Walk Test (6MWT) Distance | Baseline, Visit 2 (42 days) , Visit 3 (56 days) and Visit 4 (98 days) | The 6-minute walk test measures the distance walked in a 6-minute period (in metres), and is a validated measure of exercise endurance that has been used as an outcome in previous clinical trials for mitochondrial disease. The minimum possible distance is 0 metres, with no predefined maximum. Higher distances indicate better functional exercise capacity (better outcome). |
| Secondary | 10-Metre Walk Assessment (10 MWA) Distance | Baseline, Visit 2 (42 days) , Visit 3 (56 days) and Visit 4 (98 days) | 10-metre walk with gait assessment: The first 10 metres of the 6-minute walk test will be videotaped and timed. The time required to walk 10 metres will be recorded in seconds, with shorter times indicating better walking performance (better outcome).Video will be analyzed by a neurologist for any changes in ataxia and gait pattern. |
| Secondary | Fatigue Severity Scale (FSS) | Baseline, Visit 2 (42 days) , Visit 3 (56 days) and Visit 4 (98 days) | The Fatigue Severity Scale (FSS) is a 9-item self-reported questionnaire that assesses fatigue severity and its impact on daily activities and functioning. Each item is scored from 1 to 7, yielding a total score ranging from 9 (minimum score) to 63 (maximum score). Higher scores indicate greater fatigue severity (worse outcome). |
| Secondary | Modified Fatigue Impact Scale (MFIS) | Baseline, Visit 2 (42 days) , Visit 3 (56 days) and Visit 4 (98 days) | Modified Fatigue Impact Scale (MFIS) is a 21-item self-reported questionnaire measuring the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 84. Higher scores indicate a greater impact of fatigue on daily functioning (worse outcome). |
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.
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/NCT07887412
GET https://conductscience.org/api/trials/v1/NCT07887412/registered