Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT02045667
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years of age
2. Genetically confirmed diagnosis of NDMs
3. Participation in the "Genetical variability of the Non-dystrophic Myotonia" study of J. Trip or a new patient with genetically confirmed NDM.
Exclusion Criteria:
1. Inability or unwillingness to provide informed consent.
2. Other neurological conditions that might affect the assessment of the study measurements.
3. Genetic confirmed Myotonic Dystrophy type 1 (DM1) (CTG \> 50 repeats), or Myotonic Dystrophy type 2 (DM2).
4. Patients with existing cardiac conduction defects, evidenced on ECG including but not limited to the following conditions: malignant arrhythmia or cardiac conduction disturbances (such as second degree AV block, third degree atrio-ventricular (AV) block, or prolonged QT interval \>500 ms or QRS duration \> 150 msec).
5. Current use of the following antiarrhythmic medication for a cardiac disorder:flecainide acetate, encainide, disopyramide, procainamide, quinidine, propafenone or mexiletine.
6. Women who are pregnant or lactating.
7. Patients currently on medications for myotonia such as phenytoin and flecainide acetate within 5 days of enrollment, carbamazepine and mexiletine within 3 days of enrollment, or propafenone, procainamide, disopyramide, quinidine and encainide within 2 days of enrollment.
8. Patients with renal or hepatic disease, heart failure, history of myocardial infarction, or seizure disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02045667
Study Brief:
Protocol Section:
NCT02045667