Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT05639257
Eligibility Criteria:
Inclusion Criteria:
1. Capable adult women and men (age ≥ 18 years).
2. Diagnosed with Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, or Hyperkalemic periodic paralysis.
3. Myotonia under treatment or which significantly limits the daily activities (MBS\> 2).
Exclusion Criteria:
1. Allergy to lamotrigine, mexiletine, or the inactive ingredients in trial medication.
2. Disease, which is affected by trial medication such as heart disease (ischemia and arrhythmia), epilepsy, and significant renal or hepatic failure.
3. Treatment that, in the opinion of the project manager, can affect the study result - medication with significant interactions with trial medication.
4. In case of smoking, start or cessation during the study.
5. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05639257
Study Brief:
Protocol Section:
NCT05639257