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Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared with patients' current treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frovatriptan | Experimental | Frovatriptan 2.5 mg oral tablet |
|
| Usual Care | Active Comparator | Usual care includes the current treatment used to treat all episodes of migraine headache |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frovatriptan | Drug | This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases:
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache pain severity | Visit - V1(Day 0), V2 (Day 28), V3 (Day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia) | ||
| Occurrence and severity of functional impairment during menstrual migraine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Director | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stratford | Connecticut | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20236340 | Derived | MacGregor EA, Victor TW, Hu X, Xiang Q, Puenpatom RA, Chen W, Campbell JC. Characteristics of menstrual vs nonmenstrual migraine: a post hoc, within-woman analysis of the usual-care phase of a nonrandomized menstrual migraine clinical trial. Headache. 2010 Apr;50(4):528-38. doi: 10.1111/j.1526-4610.2010.01625.x. Epub 2010 Mar 2. |
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|
| Usual Care | Drug | Current treatment used to treat all migraine headaches |
|
| Use of rescue medication and additional frovatriptan dose |
| Patient satisfaction with treatment |
| Patient preference of current vs. study treatment (end of study only) |
| Safety as assessed by occurrence of AEs |
| Clearwater |
| Florida |
| United States |
| Jacksonville | Florida | United States |
| Largo | Florida | United States |
| Tampa | Florida | United States |
| Blackwood | New Jersey | United States |
| New York | New York | United States |
| Plainview | New York | United States |
| Vestal | New York | United States |
| Burlington | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Salisbury | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| West Chester | Ohio | United States |
| Norristown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Saint Petersburg | Pennsylvania | United States |
| Upland | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C108128 | frovatriptan |
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