Multi-Center, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of CAP3 in the Treatment of Acute Migraine

Capnia, Inc.0 个研究点目标入组 198 人开始时间: 2005年5月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Subject has a minimum 12-month migraine history that the investigator determines meets the IHS Migraine Diagnostic Criteria for migraine with or without aura.
•2.Subject is between 18-65 years of age.
•3.Subject experiences an average of 2-6 migraines per month.
•4.If on preventive migraine therapy, medication regimen has been stable for 3 months and will remain stable for the duration of participation.
•5.Subject is able to communicate adequately and comply with the requirements of the study as determined by the investigator.
•6.Subject is able to read and understand the informed consent and voluntarily agrees to sign the informed consent form
•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) no
•F.1.3.1 Number of subjects for this age range

•1.Subject’s age of migraine onset is greater than 50 years.
•2.Subject has more than 10 non-migraine headache days per month.
•3.Subject has less than 48 hours of freedom from headache between attacks of migraine.
•4.Subject is pregnant or lactating.
•5.Subject has history of alcohol or drug abuse within the past 2 years.
•6.Subject has existing serious medical condition (i.e., severe emphysema) that precludes participation.
•7.Subject participating in another clinical trial during or within 30 days prior to study enrolment.
•8.Subject has participated in more than 2 acute migraine attack studies in the 2 years prior to study enrollment.

发起方