EUCTR2006-001039-23-IT进行中（未招募）不适用
A Pilot Phase II Study for the evaluation of efficacy and tolerability of Gammaidroxybutyrate (ALCOVER) administered by oral route as add on treatmant in patients affected by DYT 11 Myoclonic Dystonia. - ND
ISTITUTO NEUROLOGICO CARLO BESTA0 个研究点开始时间: 2007年9月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Male and females > 17 years. Diagnosis of myoclonic dystonia genetically confirmed (mutation of epsilon sarcoglycan gene, 7q21-q31; DYT 11). Refractory to treatment with conventional medications. No contraindications to GHB. Written informed consent.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Serious medical and/or psychiatric diseases. More than two concomitant medications for myoclonic dystonia therapy and/or modifications of concomitant therapy in the last month prior to basal visit. Alcohol or drug abuse (last 2 years). Pregnant or lactating females. Subjects who received an experimantal drug or have participated in a clinical trial within 3 months prior to screening.
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