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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capnia, Inc.

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