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临床试验/EUCTR2021-003784-94-DK
EUCTR2021-003784-94-DK进行中(未招募)1 期

Treatment of Myotonia - Lamotrigine versus Namuscla

Rigshospitalet, department of Neurology0 个研究点目标入组 32 人开始时间: 2021年11月30日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
32

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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).

研究者

发起方
Rigshospitalet, department of Neurology

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