Trial · NCT06523400
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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) |
| Secondary | Mean change in Myotonic Dystrophy Health Index (MDHI) score (DM1 patients) | 26 weeks | Mean change in Myotonic Dystrophy Health Index (MDHI) score (DM1 patients) as measured by patient's perceived health |
| Secondary | Mean change in Myotonic Dystrophy 2 Health Index (MD2HI) score (DM2 patients) | 26 weeks | Mean change in Myotonic Dystrophy 2 Health Index (MDHI) score (DM2 patients) as measured by patient's perceived health |
| Secondary | Assess the safety of mexiletine PR by changes in ECG | 26 weeks | Mean change in ECG (PR, QRS, QTc intervals, average HR) from baseline |
| Secondary | Assess the safety of mexiletine PR by AEs | 26 weeks | Incidence of treatment emergent adverse events (TEAEs), treatment-related TEAEs, serious AEs, and patient discontinuation rate |
| Secondary | Assess the safety of mexiletine PR by standard clinical laboratory evaluations | 26 weeks | Assess the safety of mexiletine PR by standard clinical laboratory evaluations as measured by hematology, chemistry, and urinalysis assessments from change in baseline |
| Secondary | Assess the safety of mexiletine PR by vital signs | 26 weeks | Assess the safety of mexiletine PR by vital signs (pulse, respiration, body temperature, and blood pressure) from change in baseline |
| Secondary | Assess the safety of mexiletine PR by physical examinations | 26 weeks | Assess the safety of mexiletine PR by change in baseline from physical examinations |
| Secondary | To assess the pharmacokinetics of mexiletine PR | 26 weeks | To assess the pharmacokinetics of mexiletine PR as measured by PK parameter AUC0-t |
| Secondary | To assess the pharmacokinetics of mexiletine PR by AUC0-t | 26 weeks | To assess the pharmacokinetics of mexiletine PR as measured by PK parameter AUC0-t (area under the concentration-time curve from time zero to last timepoint) |
| Secondary | To assess the pharmacokinetics of mexiletine PR by Cmax | 26 weeks | To assess the pharmacokinetics of mexiletine PR as measured by PK parameter Cmax (maximum plasma concentration) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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