NCT01617941撤回2 期
A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled, Study in Patients With Non-chronic Migraine to Assess the Efficacy, Safety and Tolerability of BID Oral Doses of BGG492 in Migraine Prevention.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Frequency of migraine attacks
研究概览
简要总结
It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female smoking and non-smoking subjects of 18 to 65 years of age (inclusive)
- •Patients diagnosed with non-chronic migraine with or without aura of duration of at least 12 months prior to the study start
- •Patient diagnosed with migraine (according to the International Headache Society categories 1.1 and with equal to/more than 3 and equal to/ less than 12 migraine attacks per 4 weeks for each of the last 6 months preceding the Screening
- •Patients willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance
排除标准
- •Patients diagnosed with basilar, ophthalmoplegic or hemiplegic migraine as shown in the current/past medical history.
- •Patients having an experience of non-migraine headaches on more than 6 days per 4 weeks in the past 6 months prior to study start
- •Patients receiving regular treatment during the four (4) weeks preceding the Baseline with psychoactive drugs (e.g. hypnotics, benzodiazepines, neuroleptics) except antidepressants (eg. SSRIs, SNRIs, Tri- or Tetracyclics).
- •Patients receiving migraine prevention medications during past three (3) months preceding Baseline
- •Patients receiving topiramate as migraine prevention medication during past six (6) months preceding Baseline
- •Patients receiving metamizole as acute treatment of migraine during past three (3) months preceding Baseline
- •Patients using (or having used within four (4) weeks before the treatment start) drug treatments that are potent inhibitors of OATP transporters (e.g. rifampin).
- •Any psychiatric condition (e.g., schizophrenia, dementia, bipolar disorder) as shown in the past medical history prior to study start
- •Patients with recent (within the last three [3] years prior to study start) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, orthostatic hypotension etc.).
- •Pregnant or nursing (lactating) women. Baselines (1 and 2).
- •Patients with history of drug or alcohol abuse within the 12 months prior to dosing Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BGG492
Experimental
At Baseline 60 patients will be randomized to receive BGG492 for the upcoming 12 weeks (dose: 75 mg BID administered in approx. 12 hours +/- 2 hours intervals).
干预措施: BGG492 (Drug)
Placebo
Placebo Comparator
At Baseline 30 patients will be randomized to receive Placebo for the upcoming 12 weeks (matching a dose of 75 mg BID BGG492 administered in approx. 12 hours +/- 2 hours intervals).
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of migraine attacks
时间窗: 12 weeks
50% responder rate (equal to or more than 50 % reduction in attack frequency during the last 4-weeks of the 12-weeks treatment period compared with the 4-weeks Baseline period)
次要结局
- Number of migraine attacks(12 weeks)
研究者
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