MEND: MExiletine versus lamotrigine in Non-Dystrophic myotonias
Research type
Research Study
Full title
A phase III, randomised, double blinded, head-to-head, single-site, cross-over trial of lamotrigine versus mexiletine for non-dystrophic myotonias.
IRAS ID
288912
Contact name
Vinojini Vivekanandam
Contact email
Sponsor organisation
University College London
Eudract number
2020-003375-17
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
UCL Data Protection, No Z6364106/2020/09/11
Duration of Study in the UK
3 years, 7 months, 31 days
Research 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. Mexiletine is the current first line treatment but is difficult to access, expensive, cannot be used in pregnancy, a third of patients develop side effects and it cannot be used in patients with cardiac disease. Lamotrigine is a commonly used, well tolerated and a readily available medication that has been shown to be effective in reducing myotonia. It can also be used in pregnancy. This head to head trial aims to determine if Lamotrigine is non-inferior to Mexiletine and hence may change clinical practice by being used as the first line treatment.
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 our clinical service, national registry and national liaison. An interim statistical analysis will be undertaken half way through recruitment and at the completion of the study.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0018
Date of REC Opinion
11 Feb 2021
REC opinion
Further Information Favourable Opinion