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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
292
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Capnia Investigative Site
Birmingham, Alabama, United States
Capnia Investigative Site
Stanford, California, United States
The proportion of patients who are pain-free
Time frame: 2 hours post study drug administration
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Capnia Investigative Site
East Hartford, Connecticut, United States
Capnia Investigative Site
West Palm Beach, Florida, United States
Capnia Investigative Site
Chicago, Illinois, United States
Capnia Investigative Site
North Dartmouth, Massachusetts, United States
Capnia Investigative Site
Wellesley Hills, Massachusetts, United States
Capnia Investigative Site
Ann Arbor, Michigan, United States
Capnia Investigative Site
Kalamazoo, Michigan, United States
Capnia Investigative Site
Springfield, Missouri, United States
...and 5 more locations