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:
相关药物
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
相似试验
招募中
不适用
Treatment of Myotonia - Lamotrigine Versus NamusclaNon-Dystrophic MyotoniaNCT05639257Grete Andersen, MD32
进行中(未招募)
不适用
Better treatment of muscle diseasesMyotonia is a symptom seen certain inherited muscle dystrophies and pure channelopathies (Dystrophia myotonica type 1 and 2, Myotonia Congenita, Paramyotonia Congenita, Hyperkalæmisk periodic paralysis and Potassium-Aggravated myotonia). Genetically, mutations in chloride, sodium or calcium ion channels in the muscle is present. Myotonia manifests during physical activity where the muscle can locks in the middle of a movement. Patients are limited in their physical as well as social activities.MedDRA version: 14.1Level: PTClassification code 10061533Term: MyotoniaSystem Organ Class: 10029205 - Nervous system disordersEUCTR2013-003309-24-DKGrete Andersen
已完成
3 期
Lamotrigine as Treatment of MyotoniaDystrophia Myotonica Type 1Myotonia CongenitaParamyotonia CongenitaHyperkalemic Periodic ParalysisPotassium-Aggravated MyotoniaNCT01939561Grete Andersen, MD27
已完成
2 期
Epilepsy management in elderlyElderly epilepsy.EpilepsyIRCT2013021211560N3Deputy of Research,Tehran University of Medical Sciences95
终止
3 期
Efficacy of Lithium versus Lamotrigine for the treatment of bipolar II disorderACTRN12616001702404Professor Gordon Parker44
