Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00690716
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Capnia, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Nasal CO2 Drug: Inactive Placebo Phase 2

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
Nasal CO2
 Drug: Nasal CO2
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Placebo Comparator: 2
Inactive Placebo
 Drug: Inactive Placebo
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The proportion of patients who are pain-free [ Time Frame: 2 hours post study drug administration ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690716


Locations
Layout table for location information
United States, Alabama
Capnia Investigative Site
Birmingham, Alabama, United States, 35233
United States, California
Capnia Investigative Site
Stanford, California, United States, 94305
United States, Connecticut
Capnia Investigative Site
East Hartford, Connecticut, United States, 06118
United States, Florida
Capnia Investigative Site
West Palm Beach, Florida, United States, 33407
United States, Illinois
Capnia Investigative Site
Chicago, Illinois, United States, 60647
United States, Massachusetts
Capnia Investigative Site
North Dartmouth, Massachusetts, United States, 02747
Capnia Investigative Site
Wellesley Hills, Massachusetts, United States, 02481
United States, Michigan
Capnia Investigative Site
Ann Arbor, Michigan, United States, 48104
Capnia Investigative Site
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Capnia Investigative Site
Springfield, Missouri, United States, 65807
Capnia Investigative Site
St. Louis, Missouri, United States, 63141
United States, Pennsylvania
Capnia Investigative Site
Philadelphia, Pennsylvania, United States, 19107
Capnia Investigative Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Capnia Investigative Site
Nashville, Tennessee, United States, 37203
United States, Washington
Capnia Investigative Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Capnia, Inc.
Investigators
Layout table for investigator information
Study Chair: Roger K. Cady, MD Clinvest
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Capnia, Inc.
ClinicalTrials.gov Identifier: NCT00690716     History of Changes
Other Study ID Numbers: C112
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012
Keywords provided by Capnia, Inc.:
Nasal CO2
Phase II
Adaptive
Randomized
Double-Blind
Placebo-Controlled
 Multiple-Dose
Multi-center
Safety
Efficacy
Mild Headache
Migraineur
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms