NCT00904098

Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine

Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Menstrual Migraine (MM) Headaches

Interventions

Type	Name	Description
DRUG	Frovatriptan	This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases: 1. A Usual Care phase (approximately 1 month in duration) included one menstrual period during which female patients treated all episodes of migraine headaches using their current treatment (referred to as the Baseline phase in the protocol) 2. An Acute Treatment phase (approximately 1 month in duration), following the Usual Care phase, included one menstrual period during which female patients used frovatriptan 2.5 mg to treat all episodes of migraine headache when their headache reached IHS Grade 1. If needed, a second dose of frovatriptan 2.5 mg was administered; however, this second dose could not be administered within 2 hours of the initial dose (i.e., there must have been at least 2 hours between doses of frovatriptan). The total daily dose of frovatriptan was not to exceed 3 tablets over a 24-hour period.
DRUG	Usual Care	Current treatment used to treat all migraine headaches

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2009-05-19
• Last updated: 2010-02-15

Locations

21 sites across 1 country: United States