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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.

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 5, 2008
Last Update Posted Date August 15, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
The proportion of patients who are pain-free [ Time Frame: 2 hours post study drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00690716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Nasal CO2
    Intervention: Drug: Nasal CO2
  • Placebo Comparator: 2
    Inactive Placebo
    Intervention: Drug: Inactive Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2010)
292
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
220
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690716
Other Study ID Numbers  ICMJE C112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Capnia, Inc.
Study Sponsor  ICMJE Capnia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roger K. Cady, MD Clinvest
PRS Account Capnia, Inc.
Verification Date August 2012

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