Acute Migraine, Migraine, Migraine Disorders, Migraine Headache
Conditions
Keywords
Acute Migraine Treatment, Migraine Treatment, Migraine, Headache, Treatment
Brief summary
The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.
Interventions
DRUGTopical, intra-oral ketoprofen gel
Ketoprofen gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
OTHERPlacebo gel
Placebo gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
Sponsors
Behar, Caren, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Established diagnosis of Migraine as per IHS with aura * Established diagnosis of Migraine as per IHS without aura * At least 2 migraines per month * At least 18 years of age
Exclusion criteria
* Pregnancy or Lactation * Other Headache Conditions including basilar, hemiplegic, or ophthalmoplegic migraines * Chronic Daily Headache * Allergy or Sensitivity to NSAIDs * Other Severe Medical Conditions including GI bleeding, blood dyscrasias, thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment | Within 240 minutes post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals | Within 240 minutes post-treatment |
| Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment | Within 240 minutes post-treatment |
| Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment | Within 240 minutes post-treatment |
| Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals | Within 240 minutes post-treatment |
| Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment | Within 240 minutes post-treatment |
| Need for Rescue Medication between the time of dosing to 240 minutes | Within 240 minutes post-treatment |
| Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment | Within 240 minutes post-treatment |
Countries
United States
Contacts
Primary ContactCaren Behar, MD
Outcome results
None listed