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.
Phase:
Phase 2
Details
Lead Sponsor:
Hartford Hospital
Collaborators:
Dr. Reddy's Laboratories Limited Rami Burstein, PhD, Beth Israel Deaconess Medical Center