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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690716
• Other study ID #: C112
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: August 6, 2012
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2012
• Source: Capnia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

Drug:
• Nasal CO2
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
• Inactive Placebo
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache

Locations

Country	Name	City	State
United States	Capnia Investigative Site	Ann Arbor	Michigan
United States	Capnia Investigative Site	Birmingham	Alabama
United States	Capnia Investigative Site	Chicago	Illinois
United States	Capnia Investigative Site	East Hartford	Connecticut
United States	Capnia Investigative Site	Kalamazoo	Michigan
United States	Capnia Investigative Site	Nashville	Tennessee
United States	Capnia Investigative Site	North Dartmouth	Massachusetts
United States	Capnia Investigative Site	Philadelphia	Pennsylvania
United States	Capnia Investigative Site	Pittsburgh	Pennsylvania
United States	Capnia Investigative Site	Seattle	Washington
United States	Capnia Investigative Site	Springfield	Missouri
United States	Capnia Investigative Site	St. Louis	Missouri
United States	Capnia Investigative Site	Stanford	California
United States	Capnia Investigative Site	Wellesley Hills	Massachusetts
United States	Capnia Investigative Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Capnia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who are pain-free		2 hours post study drug administration	No