Status:
TERMINATED
The Effect of Nasal Carbon Dioxide in the Treatment of Moderate to Severe Migraine
Lead Sponsor:
Capnia, Inc.
Collaborating Sponsors:
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450 patients who me...
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
- Males and females ages 18 - 65 years
- Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
- At least a one-year history of migraine symptoms with or without aura
- Age at migraine onset less than 50 years
- History of 2-8 migraine attacks per month during the 3 months prior to randomization
- Females of childbearing potential must commit to using an acceptable method of birth control (e.g., oral birth control pills, intrauterine device (IUD), or a double-barrier method of contraception) through 7 days after last study drug administration. To be considered not of childbearing potential, females must be post-menopausal for at least 2 years or be surgically sterile
Exclusion
- Have less than 48 hours of freedom from headache between attacks of migraine
- Have 15 or more headache days per month
- Have migraine secondary to traumatic brain injury (TBI)
- Are unable to comply with protocol requirements
- Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participation or within 7 days after last study drug administration
- Have changed their usage of prescription migraine prophylaxis medications within 12 weeks prior to randomization
- 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 history of alcohol or drug abuse within 2 years prior to randomization
- Have a psychiatric disease which may prevent patient compliance or otherwise interfere with the ability of the patient to participate in the study
- Have a medical condition that makes study participation unwise in the opinion of the Investigator (e.g., significant COPD, heart disease, etc.)
- Have a concurrent diagnosis of temporomandibular disorders (TMD) or trigeminal neuralgia requiring treatment
- Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
- Are going to travel extensively by airplane during the 56-day treatment period (e.g., anticipated travel by airplane more than 25% of the 56-day treatment period, 14 days)
- Have a member of the same household also participating in this study
- Use of any investigational or experimental therapy within 30 days of randomization
- Have participated in another study with nasal CO2
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01253915
Start Date
January 1 2012
End Date
June 1 2013
Last Update
October 31 2013
Active Locations (3)
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1
Naval Medical Center San Diego - Dept of Neurology
San Diego, California, United States, 92134
2
Walter Reed National Military Medical Center - Dept of Neurology
Bethesda, Maryland, United States, 20889
3
Naval Medical Center Portsmouth - Dept of Neurology
Portsmouth, Virginia, United States, 23708