Which treatment are the best to reduce myotonia?

Phase 1

• Conditions: Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, and Hyperkalemic periodic paralysis; MedDRA version: 20.1Level: LLTClassification code 10049841Term: Myotonia congenitalSystem Organ Class: 100000004850; MedDRA version: 20.1Level: LLTClassification code 10076440Term: Hyperkalemic periodic paralysisSystem Organ Class: 100000004850; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2021-003784-94-DK
• Lead Sponsor: Rigshospitalet, department of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-30
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 32

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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 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. The following contraceptives are considered safe: IUDs or hormonal contraceptives (birth control pills, implants, transdermal patches, vaginal ring or prolonged-release injections).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified