MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias

• Status: Recruiting
• Trial end date: 2024-04-02
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical trial to determine if Lamotrigine is non-inferior to Mexiletine for the treatment of myotonia in patients with Non-Dystrophic Myotonia.

Non-dystrophic Myotonia is a genetic condition for which there is no cure. It affects patients for the duration of their life and impacts work, leisure and can lead to significant morbidity.

The study is a cross-over design - participants will be randomized to either lamotrigine or mexiletine first for 8 weeks and then swap over after a week wash-out to the other medication for a further 8 weeks. Participants and investigators will be blinded to the treatment schedule. 60 participants will recruited through the clinical service, national registry and national liaison.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Lamotrigine; Mexiletine

Criteria

Inclusion Criteria:

• adults (≥ 18years),

• genetically confirmed non-dystrophic myotonia (NDM),

• presence of symptomatic myotonia as reported by the participant.

Exclusion Criteria:

• concomitant medical conditions that would preclude the use of mexiletine or lamotrigine,

• evidence of severe kidney disease or severe liver impairment [estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation <60ml/min/1.73m2],

• pregnant or breastfeeding women,

• participation in other treatment studies <30days before enrolment.