NCT00690716

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Capnia, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Nasal CO2	Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
DRUG	Inactive Placebo	Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-06-05
• Last updated: 2012-08-15

Locations

15 sites across 1 country: United States