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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
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.
Current treatment used to treat all migraine headaches
Unnamed facility
Stratford, Connecticut, United States
Unnamed facility
Clearwater, Florida, United States
Headache pain severity
Time frame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
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
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
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Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Largo, Florida, United States
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Tampa, Florida, United States
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Blackwood, New Jersey, United States
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New York, New York, United States
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Plainview, New York, United States
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Vestal, New York, United States
Unnamed facility
Burlington, North Carolina, United States
...and 11 more locations