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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Capnia, Inc.
ClinicalTrials.gov Identifier:
NCT00690716
First received: June 3, 2008
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Migraine
Drug: Nasal CO2
Drug: Inactive Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Capnia, Inc.:

Primary Outcome Measures:
  • The proportion of patients who are pain-free [ Time Frame: 2 hours post study drug administration ] [ Designated as safety issue: No ]

Enrollment: 292
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690716

Locations
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
Study Chair: Roger K. Cady, MD Clinvest
  More Information

No publications provided

Responsible Party: Capnia, Inc.
ClinicalTrials.gov Identifier: NCT00690716     History of Changes
Other Study ID Numbers: C112
Study First Received: June 3, 2008
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

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:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014