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

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Menstrual Migraine (MM) Headaches

Treatments: Drug: Usual Care; Drug: Frovatriptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904098

EN3266-401

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Frovatriptan

Experimental group

Description:

Frovatriptan 2.5 mg oral tablet

Treatment:

Drug: Frovatriptan

Usual Care

Active Comparator group

Description:

Usual care includes the current treatment used to treat all episodes of migraine headache

Treatment:

Drug: Usual Care