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

Study Overview
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Brief Summary
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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.

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

Conditions
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Menstrual Migraine (MM) Headaches

Intervention / Treatment
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* Drug: Frovatriptan
* Drug: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Had MM headaches occurring between Day -2 and Day +3 of menses Had at least one year history of MM headaches Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year) Had regular predictable menstrual periods (28 ± 4 days) Exclusion Criteria: Had a history of more than 15 headache days per month As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM) Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease Had significant cerebrovascular disease, including basilar or hemiplegic migraine Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg Had severe hepatic or renal insufficiency Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frovatriptan<br>Frovatriptan 2.5 mg oral tablet | Drug: Frovatriptan<br>* This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases: 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) 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.<br>|
| Active Comparator: Usual Care<br>Usual care includes the current treatment used to treat all episodes of migraine headache | Drug: Usual Care<br>* Current treatment used to treat all migraine headaches<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache pain severity |  | Visit - V1(Day 0), V2 (Day 28), V3 (Day 56) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine