EUCTR2009-011184-36-IT进行中（未招募）不适用
Phase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia (IND #77,021) - ND
Dept. of Neurology - Univ. of Kansas Medical Center0 个研究点目标入组 60 人开始时间: 2011年9月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •At least 16 years of age 2. Clinical symptoms or signs suggestive of myotonic disorders 3. Presence of myotonic potentials on electromyography (EMG) 4. Participation in the Non-Dystrophic Myotonia Natural History study or a new patient with genetic confirmed NDM
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Inability or unwillingness to provide informed consent. 2. Other neurological conditions that might affect the assessment of the study measurements. 3. Genetic confirmed DM1 (CTG > 50 repeats), or DM2. 4. Patients with existing cardiac conduction defects, evidenced on EKG including but not limited to the following conditions: malignant arrhythmia or cardiac conduction disturbances (such as second degree AV block, third degree AV block, or prolonged QT interval >500 ms or QRS duration > 150 msec). 5. Current use of the following antiarrhythmic medication for a cardiac disorder: flecainide acetate, encainide, disopyramide, procainamide, quinidine, propafenone or mexiletine. 6. Women who are pregnant or lactating. 7. Patients currently on medications for myotonia such as phenytoin and flecainide acetate within 5 days of enrollment, carbamazepine and mexiletine within 3 days of enrollment, or propafenone, procainamide, disopyramide, quinidine and encainide within 2 days of enrollment. 8. Patients with an existing permanent pacemaker. 9. Patients with renal or hepatic disease, heart failure, or seizure disorders. 10. Patients on medications that produce myotonia. This includes one or more of the following: a. fibrate acid derivatives, b. hydroxymethylglutaryl CoA reductase inhibitors c. chloroquine d. colchicines
研究者
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