Can DFN-15 Terminate Migraine With Allodynia?

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03472378
Study type	Interventional
Source	Hartford Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	May 9, 2018
Completion date	April 12, 2019

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.