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

NCT ID: NCT00904098

Last Updated: 2010-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-02-28

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.

Conditions

Menstrual Migraine (MM) Headaches

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Frovatriptan

Frovatriptan 2.5 mg oral tablet

Group Type: EXPERIMENTAL

Frovatriptan

Intervention Type: DRUG

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.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: DRUG

Current treatment used to treat all migraine headaches

Interventions

Frovatriptan

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.

Intervention Type: DRUG

Usual Care

Current treatment used to treat all migraine headaches

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Endo Pharmaceuticals Inc.

Principal Investigators

Sr. Director

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Upland, Pennsylvania, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Stratford, Connecticut, United States

Clearwater, Florida, United States

Jacksonville, Florida, United States

Largo, Florida, United States

Tampa, Florida, United States

Blackwood, New Jersey, United States

New York, New York, United States

Plainview, New York, United States

Vestal, New York, United States

Burlington, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

West Chester, Ohio, United States

Norristown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Saint Petersburg, Pennsylvania, United States

Countries

United States

References

MacGregor EA, Victor TW, Hu X, Xiang Q, Puenpatom RA, Chen W, Campbell JC. Characteristics of menstrual vs nonmenstrual migraine: a post hoc, within-woman analysis of the usual-care phase of a nonrandomized menstrual migraine clinical trial. Headache. 2010 Apr;50(4):528-38. doi: 10.1111/j.1526-4610.2010.01625.x. Epub 2010 Mar 2.

Reference Type: DERIVED

PMID: 20236340 (View on PubMed)

Other Identifiers

EN3266-401

Identifier Type: -

Identifier Source: org_study_id