Trial · NCT06549400
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the long-term 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) who have completed MEX-DM-302 study. | 78 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 long-term 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) who have completed the MEX-DM-302 study | 78 weeks | Number and frequency of AEs/SAEs throughout the study while on treatment |
| Secondary | Mean change in VAS | 78 weeks | Score for muscle stiffness (myotonia severity) as self-reported by patients on a Visual Analog Scale (VAS) |
| Secondary | Mean change in MBS scores | 78 weeks | Mean change in Myotonia Behavior Scale (MBS) scores on a scale of 0 (no stiffness) to 5 (incapacitating stiffness) |
| Secondary | Mean change in health-related quality of life | 78 weeks | Mean change in health-related quality of life (measured by INQoL) |
| Secondary | Mean change in DM1-Activ-c scale (DM1 patients only) | 78 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 | 78 weeks | Mean change in time (seconds) to perform the 10-meter Walk Test (10mWT) |
| Secondary | Mean change in handgrip relaxation time | 78 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 | 78 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 | 78 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) | 78 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) | 78 weeks | Mean change in Myotonic Dystrophy 2 Health Index (MDHI) score (DM2 patients) as measured by patient's perceived health |
| Secondary | Assess the long-term safety of mexiletine PR by changes in ECG | 78 weeks | Mean change in ECG (PR, QRS, and QTc intervals in units of milliseconds \[ms\]) from baseline |
| Secondary | Assess the long-term safety of mexiletine PR by changes in ECG (HR) | 78 weeks | Mean change in ECG (HR in units of beats per minute) from baseline |
| Secondary | Assess the long-term safety of mexiletine PR by AEs | 78 weeks | Incidence of treatment emergent adverse events (TEAEs), treatment-related TEAEs, serious AEs, and patient discontinuation rate |
| Secondary | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations (hematology measured in units of μL [microliters]) from change in baseline | 78 weeks | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations as measured by hematology parameters in units of μL: white blood cell (WBC) with differential (absolute count), red blood cells (RBC), platelet count, and red blood cell indicies. |
| Secondary | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations (hematology measured in units of % [percentage]) from change in baseline | 78 weeks | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations as measured by hematology parameters in units of %: white blood cell (WBC) and differential (percentage) and hematocrit. |
| Secondary | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations (hematology measured in g/dL [units of grams per deciliter]) from change in baseline | 78 weeks | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations as measured by hematology parameters in units of g/dL: hemoglobin. |
| Secondary | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations (chemistry measured in units of mmol/L) from change in baseline | 78 weeks | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations as measured by chemistry parameters in units of mmol/L: chloride, carbon dioxide, potassium, and sodium |
| Secondary | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations (chemistry measured in units of U/L) from change in baseline | 78 weeks | Assess the long-term safety of mexiletine PR by standard clinical laboratory evaluations as measured by chemistry parameters in units of U/L: alkaline phosphatase, aspartate aminotransferase (AST), aspartate transaminase (ALT), gamma-glutamyl transferase (GGT), and creatine phosphokinase. |
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.
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GET https://conductscience.org/api/trials/v1/NCT06549400/registered