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The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00690716•Capnia, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•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
•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

Locations (15)

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

Key Dates

Start Date

August 1, 2008

Primary Completion Date

June 1, 2009

Completion Date

June 1, 2009

Last Updated

August 15, 2012

Enrollment

292

ACTUAL participants

Conditions

Migraine

Interventions

Nasal CO2

DRUG

Inactive Placebo

DRUG

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

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RECRUITINGPHASE3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.