The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
This study has been completed.
Sponsor:
Capnia, Inc.
Information provided by (Responsible Party):
Capnia, Inc.
ClinicalTrials.gov Identifier:
NCT00690716
First received: June 3, 2008
Last updated: August 6, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: Nasal CO2 Drug: Inactive Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Capnia, Inc.:
Primary Outcome Measures:
- The proportion of patients who are pain-free [ Time Frame: 2 hours post study drug administration ] [ Designated as safety issue: No ]
| Enrollment: | 292 |
| Study Start Date: | August 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 of mild headaches. An estimated 250 patients who meet the eligibility criteria will be enrolled into this study at approximately 15 sites to ensure that about 220 patients are randomized and complete the study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690716
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690716
Locations
| 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 | |
Sponsors and Collaborators
Capnia, Inc.
Investigators
| Study Chair: | Roger K. Cady, MD | Clinvest |
More Information
| Responsible Party: | Capnia, Inc. |
| ClinicalTrials.gov Identifier: | NCT00690716 History of Changes |
| Other Study ID Numbers: | C112 |
| Study First Received: | June 3, 2008 |
| Last Updated: | August 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Capnia, Inc.:
|
Nasal CO2 Phase II Adaptive Randomized Double-Blind Placebo-Controlled |
Multiple-Dose Multi-center Safety Efficacy Mild Headache Migraineur |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on September 23, 2016