The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT00690716

Run by

Capnia, Inc.

People needed

292

Starts

2008-08-01

Expected to finish

2009-06-01

Last updated by the study team

2012-08-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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