The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
NCT ID: NCT00690716
Last Updated: 2012-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
292 participants
INTERVENTIONAL
2008-08-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Nasal CO2
Nasal CO2
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
2
Inactive Placebo
Inactive Placebo
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Interventions
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Nasal CO2
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Inactive Placebo
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Capnia, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roger K. Cady, MD
Role: STUDY_CHAIR
Clinvest
Locations
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Capnia Investigative Site
Birmingham, Alabama, United States
Capnia Investigative Site
Stanford, California, United States
Capnia Investigative Site
East Hartford, Connecticut, United States
Capnia Investigative Site
West Palm Beach, Florida, United States
Capnia Investigative Site
Chicago, Illinois, United States
Capnia Investigative Site
North Dartmouth, Massachusetts, United States
Capnia Investigative Site
Wellesley Hills, Massachusetts, United States
Capnia Investigative Site
Ann Arbor, Michigan, United States
Capnia Investigative Site
Kalamazoo, Michigan, United States
Capnia Investigative Site
Springfield, Missouri, United States
Capnia Investigative Site
St Louis, Missouri, United States
Capnia Investigative Site
Philadelphia, Pennsylvania, United States
Capnia Investigative Site
Pittsburgh, Pennsylvania, United States
Capnia Investigative Site
Nashville, Tennessee, United States
Capnia Investigative Site
Seattle, Washington, United States
Countries
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Other Identifiers
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C112
Identifier Type: -
Identifier Source: org_study_id
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