Trial · NCT07097701
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 compare the safety of mexiletine PR vs mexiletine IR by incidence of treatment emergent Adverse Events (TEAEs), treatment-related TEAEs, serious AEs, and patient discontinuation rate between mexiletine PR and mexiletine IR after 12 weeks of treatment. | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by incidence of treatment emergent Adverse Events (TEAEs), treatment-related TEAEs, serious AEs, and patient discontinuation rate between mexiletine PR and mexiletine IR after 12 weeks of treatment. |
| Primary | To compare the safety of mexiletine PR vs mexiletine IR by mean change from baseline in QTc intervals by12-lead in ECG | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by mean change from baseline in QTc Intervals by12-lead in ECG |
| Primary | To compare the safety of mexiletine PR vs mexiletine IR by mean change from baseline in PR intervals by12-lead in ECG | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by mean change from baseline in PR intervals by12-lead in ECG. |
| Primary | To compare the safety of mexiletine PR vs mexiletine IR by mean change from baseline in QRS intervals by12-lead in ECG | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by mean change from baseline in QRS intervals by12-lead in ECG |
| Primary | To compare the safety of mexiletine PR vs mexiletine IR by mean change from baseline by average minimum heart rate by12-lead in ECG | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by mean change from baseline in average heart rate by 12-lead in ECG |
| Primary | To compare the safety of mexiletine PR vs mexiletine IR by performing physical examiniations | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by performing physical examinations. The investigator will complete a physical examination including the following regions and systems: general appearance, head and neck, heart, lung, abdomen, chest and back, upper extremities, lower extremities, neurological, and dermatological. In addition, height and weight will be recorded. |
| Primary | To compare the safety of mexiletine PR vs mexiletine IR by assessing vital signs | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by assessing vital signs. Vital signs will be obtained at each study visit and will include pulse, respiration, body temperature, and blood pressure. Unscheduled vital sign measurements may be obtained at the investigator's discretion during the study. |
| Primary | To compare the safety of mexiletine PR vs mexiletine IR by performing standard clinical laboratory evaluations | Baseline to week 24 | To compare the safety of mexiletine PR vs mexiletine IR for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonias (myotonia congenita (MC), paramyotonia congenita (PC) and sodium channel myotonia (SCM)) by performing standard clinical laboratory evaluations. Clinical laboratory samples will be collected under fasting conditions and hematology, serum chemistry, and urinalysis assessments will be performed |
| Secondary | Mean change in handgrip relaxation time | Baseline to week 24 | Opening Time (VHOT) functional evaluation by mean change in maximal voluntary isometric contraction (MVIC) and relaxation time by Video-recording of Hand. The dominant wrist and hand are placed on a bedside table with the forearm fully supinated. The patient is asked to open the hand after making a tight fist for 3-5 seconds 2 times within 30 minutes. |
| Secondary | Mean change in health-related quality of life | Baseline to week 24 | Mean change in health-related quality of life (measured by INQoL) on a 7-point Likert scale |
| Secondary | Mean change in MBS scores | Baseline to week 24 | Mean change in Myotonia Behavior Scale (MBS) scores on a 0-5 rating scale |
| Secondary | Mean change in time to perform Timed-up and go (TUG) test | Baseline to week 24 | Mean change in time (seconds) to perform Timed-up and go (TUG) test |
| Secondary | Mean change in VAS | Baseline to week 24 | Score for muscle stiffness (myotonia severity) as self-reported by patients on a Visual Analog Scale (VAS) on a 1-100 rating scale. |
| Secondary | Mean change in Clinical Global Impression (CGI) - Efficacy Scale | Baseline to week 24 | Score for Clinical Global Impression (CGI) - Efficacy by a 5 rating scale of No Symptoms to Very Severe |
| Secondary | Mean change in Clinical Global Impression (CGI) - Tolerability Index Scale | Baseline to week 24 | Mean change in Clinical Global Impression (CGI) - Tolerability Index Scale by a 7 rating scale of much worse to much better |
| Secondary | Mean change in time to perform the 10-meter Walk Test | Baseline to week 24 | Mean change in time (seconds) to perform the 10-meter Walk Test (10mWT) 10mWT is a performance-based test assessing walking in two different conditions, own preferred speed and maximum speed, over a short distance. The time taken to walk 10 meters at usual comfortable and maximum speed is recorded with a stopwatch. |
| Secondary | Mean change in Gastrointestinal function: The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQoL) | Baseline to week 24 | Mean change in Gastrointestinal function: The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQoL) by a 5 scale of no symptoms to Symptoms are incapacitating, unable to do daily activities |
| Secondary | Mean change in CMRS Scale | Baseline to week 24 | Mean change in Clinical myotonia rating scale (CMRS) |
| Secondary | Mean change Swallowing function | Baseline to week 24 | Mean change in Swallowing function: timed testing of swallowing |
| Secondary | Preference between the two study treatments | Baseline to week 24 | Patients were also asked to give their preference between the 2 periods of treatment and to provide the primary reasons for their choice. |
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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