Migraine Clinical Trial
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
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)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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