NCT00893594Unknown不适用
A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura
Dent Neurologic Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn).
研究概览
简要总结
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 18 to 50 years of age, inclusive.
- •Patients will meet the International Headache Society (IHS) classification criteria for migraine with aura.
- •Subjects must carry the diagnosis of 1-2 migraine with aura per month for at least three months before study inclusion. and migraine with aura were included in the study
- •Subjects must have an onset of a visual aura that occurs 15-30 minutes before a migraine headache.
- •Subjects must be able to understand and complete a migraine diary.
- •Subjects must be able to distinguish a migraine with aura from other types of headache.
- •Subjects must be in generally good health as confirmed by medical and medication history, baseline physical and neurological exam and vital signs.
- •Female subjects must be either a) postmenopausal for one year, b)surgically sterile, c) practicing acceptable birth control for at least one month prior to screening and throughout study, or d) practicing abstinence and agree to continue same throughout study.
排除标准
- •Subjects who have a significant systemic disease other than migraine that is equally painful or more painful.
- •Subjects who have other progressive neurological disorders.
- •Subjects who have more than 8 migraines or 15 headache days per month.
- •Subjects who have previously taken Treximet and failed due to lack of efficacy or adverse side effects.
- •Subjects who carry the diagnosis of chronic tension type headache or cluster headache based on the International Headache Society criteria.
- •Subject should not have received any other investigative drug within 3 months prior to enrollment in the study.
- •Subject who have the diagnosis of seizure disorder, chronic daily headache, uncontrolled hypertension, cardiovascular disease, history of stroke, basilar or hemiplegic migraine, hepatic disease, or active peptic ulcer disease.
- •Subjects currently taking or in 3 months prior to study, use of prophylactic migraine medications.
- •Subjects who have a known allergy to Sumatriptan or Naprosyn.
- •Subjects who in the opinion of Dr. Mechtler have a condition for which they should not be enrolled in the study.
研究组 & 干预措施
1
Placebo Comparator
Placebo taken at onset of aura associated with migraine.
干预措施: placebo (Drug)
2
Active Comparator
Sumatriptan with naprosyn taken at onset of aura associated with migraine.
干预措施: sumatriptan with naprosyn (Drug)
结局指标
主要结局
Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn).
时间窗: 2 and 4 hours
次要结局
- Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours.(2 and 4 hours)
研究者
Mary Kay Betz, MS RPA-C
Physician Assistant
Dent Neurologic Institute
研究点 (1)
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