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

Completed · Phase 4

Conditions studied: Menstrual Migraine (MM) Headaches

In brief

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.

Key facts

Study ID

NCT00904098

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

192

Starts

2005-09-01

Expected to finish

2006-02-01

Last updated by the study team

2010-02-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Stratford, Connecticut, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Blackwood, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Plainview, New York, United States
• Study site — Vestal, New York, United States
• Study site — Burlington, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — West Chester, Ohio, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Saint Petersburg, Pennsylvania, United States
• Study site — Upland, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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