Can DFN-15 Terminate Migraine With Allodynia?
Can DFN-15 Terminate Migraine With Allodynia?
The majority of migraineurs seeking secondary or tertiary medical care develop cutaneous
 allodynia during the course of migraine, a sensory abnormality mediated by sensitization of
 central trigeminovascular neurons in the spinal trigeminal nucleus. Triptan therapy can
 render allodynic migraineurs pain-free within a narrow window of time (20-120 min) that opens
 with the onset of pain and closes with the establishment of central sensitization. This calls
 for the development of drugs that can tackle ongoing central sensitization and render
 allodynic migraineurs pain-free after the window for triptan therapy has expired. There are
 two main objectives the investigators seek to achieve from this study: to determine whether
 oral administration of DFN-15 (solution of a COX2 inhibitor, Celecoxib) terminates migraine
 attacks when given to allodynic participants 3 hours after attack onset; and to determine
 whether mechanical and heat allodynia that develop during acute migraine attacks could be
 reversed by late (> 3hrs after attack onset) treatment with DFN-15. Participants will be
 recruited from the Headache Center and randomized in a double-blinded fashion to receive
 either the active drug (DFN-15) or placebo in a ratio of 4:1.The participants will be
 instructed to return to the clinic during a migraine. At the 'during-migraine' visit, which
 will begin 3 hours after onset of headache, the investigators will document headache
 intensity, associated symptoms, and mechanical and heat pain threshold (first) before
 treatment (at 180 min after onset of headache) and (second) at a 120 min after treatment (5
 hours after headache onset). Based on our prior experience studying migraine patients, the
 investigators plan to screen 100 patients to achieve 50 participants completing the 2 study
 visits as planned. The active drug group will consist of 80/100 patients and 20/100 patients
 will receive the placebo. The study will be terminated as soon as the first 40 participants
 who received the DFN-15 and first 10 patients who received placebo completed visit 2.
Inclusion Criteria:

 -  History of migraine with or without aura for at least 3 years, based on the
 International Classification of Headache disorders

 -  Two or more migraine attacks per month on average during the year prior to enrollment

 -  Ability to give written consent to enrollment

 Exclusion Criteria:

 -  Fifteen or more headache days per month, on average

 -  Aspirin or NSAID induced asthma or allergy

 -  Sulfa allergy

 -  Any woman who is pregnant or lactacting

 -  History of any of the following: Coronary artery bypass surgery, heart attack, angina,
 stroke, serious gastrointestinal bleeding, peptic ulcer disease, and/or chronic kidney
 disease

 -  Medical Conditions requiring the use of diuretics or daily anticoagulants

 -  Severe uncontrolled medical problems or medications that may influence measurements