NCT01319825Unknown4 期
Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.
California Medical Clinic for Headache2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline
研究概览
简要总结
This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.
详细描述
Patients with episodic migraine with and/or without aura and chronic migraine will be treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and end-of-maintenance phase headache frequencies will be recorded. There is no placebo treatment in this study. In addition to headache frequencies, other parameters being measured include safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine with or without aura or chronic migraine.
- •Subject age 18 to
- •At least 2 migraine attacks per month.
- •Willing ang able to give written informed consent.
- •Willing and able to complete the entire course of the study and to comply with study instructions.
- •Willing to taper and discontinue their current preventive medications.
排除标准
- •Subject is pregnant, lactating or planning a pregnancy in the next year.
- •Subject is female of child-bearing potential and not taking adequate forms of birth control.
- •Significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.
- •Previous failure of four or more adequate trials of preventive medication.
- •Currently on any form of antidepressant for depression and not able to discontinue.
- •Currently demonstrating medication overuse headache.
- •Currently has uncontrolled narrow angle glaucoma.
- •Currently taking monoamine oxidase inhibitors.
- •Subject has a history of seizures.
- •Participation in an investigational drug study within the last 30 days or 5 half-lives, whichever is longer.
结局指标
主要结局
Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline
时间窗: 4 months
次要结局
- Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.(4 months)
- Improvement in headache index score(4 months)
- Reduction in the number of days of headache related disability/impairment(4 months)
- Tolerability(4 months)
- Use of rescue medications(4 months)
- Quality of life measures(4 months)
研究者
研究点 (2)
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