UnknownNot Applicable

Treatment of Myotonia - Lamotrigine Versus Namuscla

Denmark32 participantsStarted 2022-12-05

Plain-language summary

In this clinical study, the aim is to investigate whether there is a difference in treatment of myotonia using two drugs. A difference there can justify the significantly higher cost when treated by Namuscla versus Lamotrigine. According to the current corona pandemic, the investigators designed an app to use for data collection in the study. The app also ensures that patients who live far from the clinic more easily can participate.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Capable adult women and men (age ≥ 18 years).
✓. Diagnosed with Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, or Hyperkalemic periodic paralysis.
✓. Myotonia under treatment or which significantly limits the daily activities (MBS\> 2).

Exclusion criteria

✕. Allergy to lamotrigine, mexiletine, or the inactive ingredients in trial medication.
✕. Disease, which is affected by trial medication such as heart disease (ischemia and arrhythmia), epilepsy, and significant renal or hepatic failure.
✕. Treatment that, in the opinion of the project manager, can affect the study result - medication with significant interactions with trial medication.
✕. In case of smoking, start or cessation during the study.
✕. Pregnant or breastfeeding during the study period. Fertile women with a positive pregnancy test at the time of entry into the trial, or who do not use safe contraception during the project period.

What they're measuring

Change in Myotonia Behavior Scale (MBS)

Timeframe: baseline and week 8

Trial details

NCT IDNCT05639257

SponsorGrete Andersen, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

Contact for this trial

Grete Andersen

35453545 grete.andersen.01@regionh.dk

View on ClinicalTrials.gov More Non-Dystrophic Myotonia trials