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

• Conditions: Acute migraine; MedDRA version: 7.1Level: PTClassification code 10027599

• Registration Number: EUCTR2004-003973-10-FI
• Lead Sponsor: Capnia, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified