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

NCT00904098 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2010-02-15

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Usual Care

Current treatment used to treat all migraine headaches

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sr. Director · Endo Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904098 on ClinicalTrials.gov