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

Sponsor

Endo Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00904098

Collaborator

(none)

192

Enrollment

Locations

Arms

Duration (Months)

9.1

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Migraine (MM) Headaches	Drug: Frovatriptan Drug: Usual Care	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Frovatriptan Frovatriptan 2.5 mg oral tablet	Drug: Frovatriptan 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.
Active Comparator: Usual Care Usual care includes the current treatment used to treat all episodes of migraine headache	Drug: Usual Care Current treatment used to treat all migraine headaches

Arm

Intervention/Treatment

Experimental: Frovatriptan

Frovatriptan 2.5 mg oral tablet

Drug: Frovatriptan

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.

Active Comparator: Usual Care

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

Drug: Usual Care

Current treatment used to treat all migraine headaches

Outcome Measures

Primary Outcome Measures

Headache pain severity [Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)]

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Stratford	Connecticut	United States
2	Clearwater	Florida	United States
3	Jacksonville	Florida	United States
4	Largo	Florida	United States
5	Tampa	Florida	United States
6	Blackwood	New Jersey	United States
7	New York	New York	United States
8	Plainview	New York	United States
9	Vestal	New York	United States
10	Burlington	North Carolina	United States
11	Raleigh	North Carolina	United States
12	Salisbury	North Carolina	United States
13	Winston-Salem	North Carolina	United States
14	Cincinnati	Ohio	United States
15	West Chester	Ohio	United States
16	Norristown	Pennsylvania	United States
17	Philadelphia	Pennsylvania	United States
18	St. Petersburg	Pennsylvania	United States
19	Upland	Pennsylvania	United States
20	Nashville	Tennessee	United States
21	Houston	Texas	United States