Trial · NCT06523400
The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2
NCT06523400, Phase 3, Recruiting, Lupin Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2. Trials, record NCT06523400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06523400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2
- NCT number
- NCT06523400
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 176 participants, estimated
- Lead sponsor
- Lupin Ltd.
- Conditions
- Myotonic Dystrophy
- Interventions
- Mexiletine granules for prolonged-release oral suspension, Placebo
- First posted
- 2024-07-26
- Last updated
- 2026-09-24
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the efficacy of once daily mexiletine PR for the symptomatic treatment of myotonia in patients with myotonic dystrophy type 1 and type 2 (DM1 and DM2). | 26 weeks | Handgrip relaxation time in DM1 patients by mean change in baseline of handgrip relaxation time (seconds) after maximal voluntary isometric contraction (MVIC) |
| Secondary | To assess the safety of once daily mexiletine PR for the symptomatic treatment of myotonia in patients with myotonic dystrophy type 1 and type 2 (DM1 and DM2). | 26 weeks | Number and frequency of AEs/SAEs throughout the study while on treatment |
| Secondary | Mean change in VAS | 26 weeks | Score for muscle stiffness (myotonia severity) as self-reported by patients on a Visual Analog Scale (VAS) |
| Secondary | Mean change in MBS scores | 26 weeks | Mean change in Myotonia Behavior Scale (MBS) scores |
| Secondary | Mean change in health-related quality of life | 26 weeks | Mean change in health-related quality of life (measured by INQoL) |
| Secondary | Mean change in DM1-Activ-c scale (DM1 patients only) | 26 weeks | Mean change in measure of activity and social participation (measured by a Rasch-built scale with a 0-100 interval range) |
| Secondary | Mean change in time to perform the 10-meter Walk Test | 26 weeks | Mean change in time (seconds) to perform the 10-meter Walk Test (10mWT) |
| Secondary | Mean change in handgrip relaxation time | 26 weeks | Mean change in maximal voluntary isometric contraction (MVIC) and relaxation time by Video-recording of Hand Opening Time (VHOT) functional evaluation |
| Secondary | Mean change in time to perform Timed-up and go (TUG) test | 26 Weeks | Mean change in time (seconds) to perform Timed-up and go (TUG) test |
| Secondary | Mean change in health-related quality of life measured by EQ-5D | 26 weeks | Mean change in health-related quality of life measured by EQ-5D (5-point scale) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
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/NCT06523400
GET https://conductscience.org/api/trials/v1/NCT06523400/registered