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NCT01406873 · ClinicalTrials.gov registry record · Phase 2
Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT01406873: Completed Phase 2 study, sponsored by University of Rochester.
NCT01406873 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01406873, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the effects of mexiletine treatment for 6 months on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning, cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).
Primary Outcome
During this assessment, participants were asked to walk as far as they could back and forth on a fixed 20 meter route for 6 minutes. The total distance walked during the 6 minutes was recorded in meters. Change from baseline was defined as the difference between the average 6 minute walk distance at baseline and the average 6 minute walk distance at 6 months.
Interventions
- DRUG Placebo
- DRUG Mexiletine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-06 |
| Est. Completion | 2017-03 |
| Phase | Phase 2 |
What the finished NCT01406873 record still lists
NCT01406873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01406873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01406873 about?
NCT01406873 is a clinical study titled "Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1". The purpose of this study is to investigate the effects of mexiletine treatment for 6 months on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning, cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).
What is the current status of trial NCT01406873?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2011-06. Estimated completion is 2017-03.
What interventions are being tested in trial NCT01406873?
The interventions under investigation include: Placebo (DRUG), Mexiletine (DRUG).
Who is sponsoring clinical trial NCT01406873?
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 NCT01406873's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 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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