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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Nasal CO2
* Drug: Inactive Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nasal CO2 | Drug: Nasal CO2<br>* Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache<br>|
| Placebo Comparator: 2<br>Inactive Placebo | Drug: Inactive Placebo<br>* Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal CO2, Phase II, Adaptive, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Multi-center, Safety, Efficacy, Mild Headache, Migraineur