An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders

Ki vehet részt

• Adult, male or female patients with non-dystrophic myotonic disorders planned to be started on Namuscla according to the approved SmPC
• Patients already receiving Namuscla/mexiletine for the treatment of NDM; (for patients on mexiletine other than Namuscla, only those who switch to Namuscla will be enrolled)
• Patients who understand and are willing to provide informed consent

Ki nem vehet részt

• Patients who are enrolled or participating in any other clinical trial for an investigational product. -
• Patients receiving drugs that can induce torsades de pointes
• Patients receiving medicinal products with narrow therapeutic index (ie, theophylline, tizanidine, digoxin, lithium, phenytoin or warfarin)
• Hypersensitivity to mexiletine, or to any of the excipients of Namuscla, or hypersensitivity to any local anaesthetic
• Complete heart block (ie, third-degree atrioventricular block) or any heart block susceptible to evolve to complete heart block (first-degree atrioventricular block with markedly prolonged PR interval (≥ 240 ms) and/or wide QRS complex (≥ 120 ms), second-degree atrioventricular block, bundle branch block, bifascicular and trifascicular block),
• Myocardial infarction (acute or past), or abnormal Q-waves
• Symptomatic coronary artery disease
• Heart failure with reduced ejection fraction <50%
• Ventricular tachyarrhythmia
• Atrial tachyarrhythmia, fibrillation or flutter
• Sinus node dysfunction (including sinus rate < 50 bpm)
• Patients who are pregnant or lactating