Status:
COMPLETED
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
Lead Sponsor:
Capnia, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines.
Detailed Description
This multi-center, adaptively randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in the treatment o...
Eligibility Criteria
Inclusion
- Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB-approved informed consent form
- Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
- History of 2-8 migraine attacks per month during the 3 months prior to randomization
- Have a typical migraine which progresses from a distinct mild headache to a moderate or severe migraine
- Able to recognize a mild headache that could develop into a moderate or severe migraine
Exclusion
- Have less than 48 hours of freedom from headache between attacks of migraine
- Have 15 or more headache days per month
- Are females who are pregnant or lactating
- Use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study
- Have a concurrent diagnosis of TMD or trigeminal neuralgia requiring treatment
- Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
- Have participated in another study with nasal CO2
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT00690716
Start Date
August 1 2008
End Date
June 1 2009
Last Update
August 15 2012
Active Locations (15)
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1
Capnia Investigative Site
Birmingham, Alabama, United States, 35233
2
Capnia Investigative Site
Stanford, California, United States, 94305
3
Capnia Investigative Site
East Hartford, Connecticut, United States, 06118
4
Capnia Investigative Site
West Palm Beach, Florida, United States, 33407