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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
History of Changes

June 3, 2008
August 6, 2012
August 2008
June 2009   (final data collection date for primary outcome measure)
The proportion of patients who are pain-free [ Time Frame: 2 hours post study drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00690716 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • Drug: Nasal CO2
    Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
  • Drug: Inactive Placebo
    Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
  • Experimental: 1
    Nasal CO2
    Intervention: Drug: Nasal CO2
  • Placebo Comparator: 2
    Inactive Placebo
    Intervention: Drug: Inactive Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690716
C112
No
Capnia, Inc.
Capnia, Inc.
Not Provided
Study Chair: Roger K. Cady, MD Clinvest
Capnia, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP