MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias

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.

Timeline

Start

2021-08-12

Primary completion

2023-08

Completion

2024-04-02

Publications

• Vivekanandam V, Skorupinska I, Jayaseelan DL, Matthews E, Barohn RJ, McDermott MP, Hanna MG. Mexiletine versus lamotrigine in non-dystrophic myotonias: a randomised, double-blind, head-to-head, crossover, non-inferiority, phase 3 trial. Lancet Neurol. 2024 Oct;23(10):1004-1012. doi: 10.1016/S1474-4422(24)00320-X.

Drugs

Indications