In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients were to visit the study site a total of 6 times. Efficacy and/or safety assessments were performed at each visit.
This Phase IIIb, open label, multi-centre study evaluated the safety and tolerability of frovatriptan taken by patients for up to 12 perimenstrual periods (PMPs) for the prevention of menstrual migraine (MM). The study required approximately 300 patients to treat 6 PMPs and 100 patients to treat 12 PMPs. To achieve these numbers, 550 patients were to be enrolled into the study. Once enrolled, patients were requested to treat at least 6 PMPs in the first 9 months and 12 PMPs overall. Patients were to remain in the study for a maximum of 15 months or until they had completed the treatment of 12 PMPs, whichever occurred sooner.Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
550
Unnamed facility
Munich, Germany
Unnamed facility
Budapest, Hungary
Unnamed facility
Warsaw, Poland
Unnamed facility
Cape Town, South Africa
Unnamed facility
London, United Kingdom
Incidence of all treatment-emergent adverse events (AEs).
Time frame: 9-15 months
Incidence of menstrual migraine headache
Time frame: 9-15 months
Maximum headache severity
Time frame: 9-15 months
Number of headache-free days during a treated perimenstrual period (PMP)
Time frame: 9-15 months
Occurrence and severity of menstrual migraine headache-associated symptoms
Time frame: 9-15 months
Maximum functional impairment during menstrual migraine headache
Time frame: 9-15 months
Incidence and severity of intercurrent migraine
Time frame: 9-15 months
Total migraine burden
Time frame: 9-15 months
Standard hematology and biochemistry
Time frame: 9-15 months
12-lead electrocardiogram (ECG) and vital signs, physical examination
Time frame: 9-15 months
Short-form 12 (SF-12) Health Related Quality of Life Questionnaire
Time frame: 9-12 months
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