Menstrual Migraine (MM) Headaches
Conditions
Keywords
migraine
Brief 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.
Interventions
DRUGFrovatriptan
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.
DRUGUsual Care
Current treatment used to treat all migraine headaches
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Had MM headaches occurring between Day -2 and Day +3 of menses 2. Had at least one year history of MM headaches 3. Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year) 4. Had regular predictable menstrual periods (28 ± 4 days)
Exclusion criteria
1. Had a history of more than 15 headache days per month 2. As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM) 3. 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 4. Had significant cerebrovascular disease, including basilar or hemiplegic migraine 5. Had uncontrolled hypertension: systolic blood pressure \>180mmHg and diastolic blood pressure \>95mmHg 6. Had severe hepatic or renal insufficiency 7. Used an analgesic medication (including both prescription and over-the-counter) for any reason \>50% of days per month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Headache pain severity | Visit - V1(Day 0), V2 (Day 28), V3 (Day 56) |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence and severity of functional impairment during menstrual migraine | — |
| Use of rescue medication and additional frovatriptan dose | — |
| Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia) | — |
| Patient preference of current vs. study treatment (end of study only) | — |
| Safety as assessed by occurrence of AEs | — |
| Patient satisfaction with treatment | — |
Countries
United States
Outcome results
None listed