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

August 6, 2012 updated by: Capnia, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

292

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Capnia Investigative Site
    • California
      • Stanford, California, United States, 94305
        • Capnia Investigative Site
    • Connecticut
      • East Hartford, Connecticut, United States, 06118
        • Capnia Investigative Site
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • Capnia Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60647
        • Capnia Investigative Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Capnia Investigative Site
      • Wellesley Hills, Massachusetts, United States, 02481
        • Capnia Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Capnia Investigative Site
      • Kalamazoo, Michigan, United States, 49009
        • Capnia Investigative Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Capnia Investigative Site
      • St. Louis, Missouri, United States, 63141
        • Capnia Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Capnia Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Capnia Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Capnia Investigative Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Capnia Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients who are pain-free
Time Frame: 2 hours post study drug administration
2 hours post study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capnia, Inc.

Investigators

  • Study Chair: Roger K. Cady, MD, Clinvest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Nasal CO2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe