Back to resultsThe Effect of Nasal Carbon Dioxide in the Treatment of Moderate to Severe Migraine
Primary Purpose
Migraine
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nasal Carbon Dioxide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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
Sites / Locations
- Naval Medical Center San Diego - Dept of Neurology
- Walter Reed National Military Medical Center - Dept of Neurology
- Naval Medical Center Portsmouth - Dept of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Carbon Dioxide
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The proportion of patients who are pain-free
Secondary Outcome Measures
The proportion of patients who are nausea/vomiting free
The proportion of patients who are phonophobia free
The proportion of patients who are photophobia free
Full Information
NCT ID
NCT01253915
First Posted
December 2, 2010
Last Updated
October 30, 2013
Sponsor
Capnia, Inc.
Collaborators
Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01253915
Brief Title
The Effect of Nasal Carbon Dioxide in the Treatment of Moderate to Severe Migraine
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment and lack of funding for study
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capnia, Inc.
Collaborators
Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbon Dioxide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nasal Carbon Dioxide
Intervention Description
10 sec/nostril up to 4 times to treat one migraine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 sec/nostril up to 4 times to treat a migraine
Primary Outcome Measure Information:
Title
The proportion of patients who are pain-free
Time Frame
at 2 hours after study drug administration
Secondary Outcome Measure Information:
Title
The proportion of patients who are nausea/vomiting free
Time Frame
at 2 hours after study drug administration
Title
The proportion of patients who are phonophobia free
Time Frame
at 2 hours after study drug administration
Title
The proportion of patients who are photophobia free
Time Frame
at 2 hours after study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Bertrand, DDS
Organizational Affiliation
National Naval Medical Center, Bethesda
Official's Role
Study Chair
Facility Information:
Facility Name
Naval Medical Center San Diego - Dept of Neurology
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Walter Reed National Military Medical Center - Dept of Neurology
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Naval Medical Center Portsmouth - Dept of Neurology
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Nasal Carbon Dioxide in the Treatment of Moderate to Severe Migraine
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