MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias (NCT05017155) | Clinical Trial Compass
UnknownPhase 3
MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias
United Kingdom60 participantsStarted 2021-08-12
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interactive Voice Response (IVR) -diary score
Timeframe: Time Frame: last two weeks of each treatment period - [Minimum value 0- no myotonia. Maximum value 9 - severe myotonia].