EUCTR2008-005167-33-DE进行中（未招募）1 期
Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •patient written informed consent
- •age 18 - 75 years
- •diagnosed with multiple sclerosis or hereditary spinocerebellar ataxia or late onset idiopathic cerebellar ataxia
- •ataxia since at least 3 months (multiple sclerosis) or 1 year (hereditary spinocerebellar ataxia and idiopathic late onset ataxia)
- •highly effective contraception for women (defined as Pearl index < 1)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •pregnancy or lactation
- •all contraindications against gabapentin
- •medication with morphine, naproxen or pregabalin, interferon
- •medication with gabapentin in past 3 months
- •no consent for Speicherung und Weitergabe of pseudonymised clinical data
- •forced hospitalization
- •Alcohol abuse in last 10 years
- •Allergy against gabapentin or another ingredient of trial medication
- •acute oder chronic pancreatitis
- •kidney insufficience
- •liver insufficience
- •no ability to walk even with assistance
- •fast disease progression (worsening in neurologic examination in last 2 months)
- •participation in another treatment trial up to 2 months before and during the GABATAX trial
研究者
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