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NCT03472378 · ClinicalTrials.gov registry record · Phase 2
Can DFN-15 Terminate Migraine With Allodynia?
A Phase 2 study, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT03472378 is a Phase 2 study that has completed, run by Hartford Hospital. The registered enrollment target is 51 participants.
The verdict
NCT03472378, a Phase 2 study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study 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
Interventions
- OTHER Placebo
- DRUG DFN-15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2019-04-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03472378
The ClinicalTrials.gov registry entry for NCT03472378 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03472378 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03472378 about?
NCT03472378 is a clinical study titled "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 pa...
What is the current status of trial NCT03472378?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2018-05-09. Estimated completion is 2019-04-12.
What interventions are being tested in trial NCT03472378?
The interventions under investigation include: Placebo (OTHER), DFN-15 (DRUG).
Who is sponsoring clinical trial NCT03472378?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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