NCT00820105终止2 期
A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multicentre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 for the Prevention of Migraine
Addex Pharma S.A.30 个研究点 分布在 4 个国家目标入组 350 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 350
- 试验地点
- 30
- 主要终点
- Number of migraine headache days during weeks 9-12 of the treatment period
研究概览
简要总结
Evaluation of ADX10059 to prevent migraine attacks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 to 65 years
- •History of migraine
- •Aged ≤ 50 years at onset of migraine history
排除标准
- •Cluster headache or chronic migraine headaches
- •Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors
- •Unable to distinguish migraine headache from tension and other types of headache
- •Current history of psychiatric disorder requiring regular medication
- •Known history of alcohol abuse
- •Known clinically significant allergy or known hypersensitivity to drugs
- •History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
- •Pregnant or breast-feeding
研究组 & 干预措施
ADX10059 25 mg
Experimental
Weeks 1-2: once daily Weeks 3-12: twice daily
干预措施: ADX10059 (Drug)
ADX10059 50 mg
Experimental
Weeks 1-2: once daily Weeks 3-12: twice daily
干预措施: ADX10059 (Drug)
ADX10059 100 mg
Experimental
Weeks 1-2: once daily Weeks 3-12: twice daily
干预措施: ADX10059 (Drug)
ADX10059 Matching Placebo
Placebo Comparator
Weeks 1-2: once daily Weeks 3-12: twice daily
干预措施: ADX10059 Matching Placebo (Drug)
结局指标
主要结局
Number of migraine headache days during weeks 9-12 of the treatment period
时间窗: 12 weeks
次要结局
- Migraine frequency(12 weeks)
- Migraine severity(12 weeks)
- Migraine duration(12 weeks)
- Occurrence of aura(12 weeks)
- Functional impairment severity(12 weeks)
- Rescue medication use(12 weeks)
- Proportion of responders(12 weeks)
- Global assessment of study medication(12 weeks)
研究者
研究点 (30)
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