Trial · NCT02561702
Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease
NCT02561702, Phase 2, Completed, University of Rochester; results first posted 2018-03-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease. Trials, record NCT02561702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02561702
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease
- NCT number
- NCT02561702
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Charcot Marie Tooth Disease
- Interventions
- Placebo, Mexiletine
- First posted
- 2015-09-28
- Last updated
- 2018-03-26
- Results first posted
- 2018-03-26
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 a Decrease in Cramp Duration | 120 minutes | Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp duration in seconds of the right hamstring was used. |
| Primary | Number of Participants With a Decrease in Cramp Intensity | 120 minutes | Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp intensity of the right hamstring was reported by the subject on a scale of 1-10 with 1 being weak and 10 being severe. |
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 a Decrease in Cramp Duration | 120 minutes | participants | NUMBER | |
| PRIMARY | Number of Participants With a Decrease in Cramp Intensity | 120 minutes | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
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 a Decrease in Cramp Duration | Mexiletine | 2 | participants | ||
| Number of Participants With a Decrease in Cramp Duration | Placebo | 0 | participants | ||
| Number of Participants With a Decrease in Cramp Intensity | Mexiletine | 1 | participants | ||
| Number of Participants With a Decrease in Cramp Intensity | Placebo | 2 | participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Mexiletine First/Placebo Second | 2 | |
| First Intervention | STARTED | Placebo First/Mexiletine Second | 2 | |
| First Intervention | COMPLETED | Mexiletine First/Placebo Second | 2 | |
| First Intervention | COMPLETED | Placebo First/Mexiletine Second | 2 | |
| First Intervention | NOT COMPLETED | Mexiletine First/Placebo Second | 0 | |
| First Intervention | NOT COMPLETED | Placebo First/Mexiletine Second | 0 | |
| Washout | STARTED | Mexiletine First/Placebo Second | 2 | |
| Washout | STARTED | Placebo First/Mexiletine Second | 2 | |
| Washout | COMPLETED | Mexiletine First/Placebo Second | 2 | |
| Washout | COMPLETED | Placebo First/Mexiletine Second | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mexiletine | 0 | 4 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | Mexiletine | 0 | 4 |
| Total, other adverse events | Placebo | 0 | 4 |
| Total, serious adverse events | Mexiletine | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 4 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mexiletine vs Placebo: Number of Participants With a Decrease in Cramp Intensity | Trial comparisons |
| Mexiletine vs Placebo: Number of Participants With a Decrease in Cramp Duration | Trial comparisons |
| Mexiletine vs Placebo: deaths from any cause | Trial comparisons |
| Mexiletine vs Placebo: serious adverse events | Trial comparisons |
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/NCT02561702
GET https://conductscience.org/api/trials/v1/NCT02561702/registered