EUCTR2014-002627-10-IT进行中（未招募）1 期
A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A or CLCN1 genes. - RILUMEX
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
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
- •- Aged at least 18 years.
- •- Clinical signs or symptoms of myotonia.
- •- Myotonic potentials on electromyography.
- •- Genetically confirmed NDM (patients mutated in SCN4A or CLCN1
- •- Written informed consent.
- •- Daily access to a personal computer and internet connection, for IWR
- •diary report.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •-Other neurological conditions that might affect the study assessments.
- •-Genetic confirmation of DM1 (more than 50 repeats of CTG) or DM2.
- •-Existing atrial flutter or fibrillation or other cardiac conduction defects, as evidenced on ECG at screening visit, including but not limited to the following conditions: malignant arrhythmia or cardiac conduction disturbances (e.g., second degree AV block, third degree AV block, or prolonged QT interval). Any cardiological controindications to mexiletine use will be excluded by a cardiologist. If required by the cardiologist, the patient will undergo heart echo scan and/or Holter ECG.
- •-Existing permanent pacemaker.
- •-Current use of any of the following antiarrhythmic medications for a cardiac disorder: flecainide acetate, encainide, disopyramide, procainamide, quinidine, propafenone, or mexiletine.
- •-Currently use of mexiletine for myotonia in 7 days before randomization.
- •-Use of medications for myotonia, such as phenytoin and flecainide acetate, within 5 days of study entry, carbamazepine within 3 days of study entry; or propafenone, procainamide, disopyramide, quinidine, and encainide within 2 days of study entry.
- •-Use of medications that produce myotonia, which may include fibrate acid derivatives, hydroxymethylglutaryl CoA reductase inhibitors, chloroquine, and colchicines.
- •-Kidney or liver disease or abnormally high levels of liver enzymes such as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), alkaline phosphatase (AP), GGT, serum bilirubin, except for Gilbert’s Disease:
- •The investigator should be guided by the following criteria:
- •¿Any single transaminase may not exceed 3x times upper limits of normal (ULN). A single parameter elevated up to and including 3 x ULN should be re-checked as soon as possible, and in all cases, at least prior to randomization, to rule out any lab error. Normal lab values are shown in table 3.
- •¿AP and/or GGT may not exceed 2x times ULN. A single parameter elevated up to and including 2 x ULN should be re-checked as soon as possible, and in all cases, at least prior to randomization, to rule out any lab error.
- •¿If the total bilirubin (TBL) concentration is increased above 1.5x ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1.6 mg/dL.
- •-Known heart failure or symptomatic cardiomyopathy or recent cardiac infarction (<3 months before randomization).
- •-Significant coagulopathy, platelet count less than 75,000/mm3, hemoglobin less than 11.0 g/dL.
- •-Seizure disorder.
- •-Currently pregnant or breastfeeding.
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