Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical, intra-oral ketoprofen gel | Active Comparator |
| |
| Placebo gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical, intra-oral ketoprofen gel | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caren Behar, MD | Contact | 914-584-2413 | ardavsa@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Caren Behar, MD | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Medical College | Valhalla | New York | 10595 | United States |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo gel | Other | 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. |
|
| 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 |
| Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment | 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 |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |