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NCT02561702 · ClinicalTrials.gov registry record · Phase 2
Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02561702: Completed Phase 2 study, sponsored by University of Rochester.
NCT02561702 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02561702, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Charcot Marie Tooth Disease is a family of inherited peripheral neuropathies, with over 70 causative genes identified to date.1-4 Muscle cramps are frequent in CMT, affecting up to 85% of patients with some subtypes of CMT. These cramps impact quality of life and have been identified as an important therapeutic target for clinical trials in CMT.1-4 There is no FDA approved treatment for muscle cramps.5 Mexiletine is a sodium channel blocker approved for treatment of arrhythmias. As a sodium channel blocker, mexiletine offers the promise of effective therapy for muscle cramps.
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG Mexiletine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 2 |
What the finished NCT02561702 record still lists
NCT02561702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02561702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02561702 about?
NCT02561702 is a clinical study titled "Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease". Charcot Marie Tooth Disease is a family of inherited peripheral neuropathies, with over 70 causative genes identified to date.1-4 Muscle cramps are frequent in CMT, affecting up to 85% of patients with some subtypes of CMT. These cramps impact quality of life and have been identified as an important...
What is the current status of trial NCT02561702?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2015-09. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT02561702?
The interventions under investigation include: Placebo (OTHER), Mexiletine (DRUG).
Who is sponsoring clinical trial NCT02561702?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02561702's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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