The Effect of Nasal Carbon Dioxide in the Treatment of Moderate to Severe Migraine

This study has been terminated.
(Low enrollment and lack of funding for study)
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
United States Naval Medical Center, Portsmouth
Madigan Army Medical Center
Information provided by (Responsible Party):
Capnia, Inc.
ClinicalTrials.gov Identifier:
NCT01253915
First received: December 2, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450 patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1 ratio to ensure that 400 patients will treat at least one moderate to severe migraine with the study drug.

Patients will be randomized to one of two treatment groups and be provided with either an active or placebo dispenser.

All patients will administer study drug for 10 seconds to each nostril when experiencing a qualifying headache. Patients will assess their pain and other migraine-related symptoms in a patient diary. If a patient still has pain and/or any other symptoms after the initial dose then the patient may opt to take 3 more doses to treat the headache.

Each patient's participation in the study may last up to 56 days or once the patient treats 4 headaches with the study drug, whichever occurs first.

There will be a total of 2 scheduled clinic visits:

  • Visit 1 Screening/Randomization
  • Visit 2 End of Study (within 7 days after the patients treats his/her fourth headache or after the end of the 56-day treatment period, whichever occurs first)

Condition Intervention Phase
Migraine
Drug: Nasal Carbon Dioxide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 Moderate to Severe Migraine

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: at 2 hours after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients who are nausea/vomiting free [ Time Frame: at 2 hours after study drug administration ] [ Designated as safety issue: No ]
  • The proportion of patients who are phonophobia free [ Time Frame: at 2 hours after study drug administration ] [ Designated as safety issue: No ]
  • The proportion of patients who are photophobia free [ Time Frame: at 2 hours after study drug administration ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbon Dioxide Drug: Nasal Carbon Dioxide
10 sec/nostril up to 4 times to treat one migraine
Placebo Comparator: Placebo Drug: Placebo
10 sec/nostril up to 4 times to treat a migraine

  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
  • Males and females ages 18 - 65 years
  • Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
  • At least a one-year history of migraine symptoms with or without aura
  • Age at migraine onset less than 50 years
  • History of 2-8 migraine attacks per month during the 3 months prior to randomization
  • Females of childbearing potential must commit to using an acceptable method of birth control (e.g., oral birth control pills, intrauterine device (IUD), or a double-barrier method of contraception) through 7 days after last study drug administration. To be considered not of childbearing potential, females must be post-menopausal for at least 2 years or be surgically sterile

Exclusion Criteria:

  • Have less than 48 hours of freedom from headache between attacks of migraine
  • Have 15 or more headache days per month
  • Have migraine secondary to traumatic brain injury (TBI)
  • Are unable to comply with protocol requirements
  • Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participation or within 7 days after last study drug administration
  • Have changed their usage of prescription migraine prophylaxis medications within 12 weeks prior to randomization
  • 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 history of alcohol or drug abuse within 2 years prior to randomization
  • Have a psychiatric disease which may prevent patient compliance or otherwise interfere with the ability of the patient to participate in the study
  • Have a medical condition that makes study participation unwise in the opinion of the Investigator (e.g., significant COPD, heart disease, etc.)
  • Have a concurrent diagnosis of temporomandibular disorders (TMD) or trigeminal neuralgia requiring treatment
  • Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
  • Are going to travel extensively by airplane during the 56-day treatment period (e.g., anticipated travel by airplane more than 25% of the 56-day treatment period, 14 days)
  • Have a member of the same household also participating in this study
  • Use of any investigational or experimental therapy within 30 days of randomization
  • 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: NCT01253915

Locations
United States, California
Naval Medical Center San Diego - Dept of Neurology
San Diego, California, United States, 92134
United States, Maryland
Walter Reed National Military Medical Center - Dept of Neurology
Bethesda, Maryland, United States, 20889
United States, Virginia
Naval Medical Center Portsmouth - Dept of Neurology
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
Capnia, Inc.
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
United States Naval Medical Center, Portsmouth
Madigan Army Medical Center
Investigators
Study Chair: Peter M Bertrand, DDS National Naval Medical Center, Bethesda
  More Information

No publications provided

Responsible Party: Capnia, Inc.
ClinicalTrials.gov Identifier: NCT01253915     History of Changes
Other Study ID Numbers: C113
Study First Received: December 2, 2010
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014