The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
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ClinicalTrials.gov Identifier: NCT00690716 |
Recruitment Status :
Completed
First Posted : June 5, 2008
Last Update Posted : August 15, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Drug: Nasal CO2 Drug: Inactive Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 292 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Nasal Carbon Dioxide in the Treatment of Mild Headache in Migraineurs |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Nasal CO2
|
Drug: Nasal CO2
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache |
Placebo Comparator: 2
Inactive Placebo
|
Drug: Inactive Placebo
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache |
- The proportion of patients who are pain-free [ Time Frame: 2 hours post study drug administration ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690716
United States, Alabama | |
Capnia Investigative Site | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Capnia Investigative Site | |
Stanford, California, United States, 94305 | |
United States, Connecticut | |
Capnia Investigative Site | |
East Hartford, Connecticut, United States, 06118 | |
United States, Florida | |
Capnia Investigative Site | |
West Palm Beach, Florida, United States, 33407 | |
United States, Illinois | |
Capnia Investigative Site | |
Chicago, Illinois, United States, 60647 | |
United States, Massachusetts | |
Capnia Investigative Site | |
North Dartmouth, Massachusetts, United States, 02747 | |
Capnia Investigative Site | |
Wellesley Hills, Massachusetts, United States, 02481 | |
United States, Michigan | |
Capnia Investigative Site | |
Ann Arbor, Michigan, United States, 48104 | |
Capnia Investigative Site | |
Kalamazoo, Michigan, United States, 49009 | |
United States, Missouri | |
Capnia Investigative Site | |
Springfield, Missouri, United States, 65807 | |
Capnia Investigative Site | |
St. Louis, Missouri, United States, 63141 | |
United States, Pennsylvania | |
Capnia Investigative Site | |
Philadelphia, Pennsylvania, United States, 19107 | |
Capnia Investigative Site | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Capnia Investigative Site | |
Nashville, Tennessee, United States, 37203 | |
United States, Washington | |
Capnia Investigative Site | |
Seattle, Washington, United States, 98104 |
Study Chair: | Roger K. Cady, MD | Clinvest |
Responsible Party: | Capnia, Inc. |
ClinicalTrials.gov Identifier: | NCT00690716 History of Changes |
Other Study ID Numbers: |
C112 |
First Posted: | June 5, 2008 Key Record Dates |
Last Update Posted: | August 15, 2012 |
Last Verified: | August 2012 |
Nasal CO2 Phase II Adaptive Randomized Double-Blind Placebo-Controlled |
Multiple-Dose Multi-center Safety Efficacy Mild Headache Migraineur |
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |