NCT00904098|CompletedPhase 4
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Sponsor study identifier
interventional
192
1 country
21
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2006
Actual (reported)Study Completion
February 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
February 2006
Actual (reported)February 2006
Actual (reported)May 15, 2009
Actual (reported)May 19, 2009
Actual (reported)Headache pain severity
Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
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)
Frovatriptan 2.5 mg oral tablet
Usual care includes the current treatment used to treat all episodes of migraine headache
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.
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
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.
Sr. Director
Endo USA Inc., a Keenova Therapeutics Company
192 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2009
First Posted
May 19, 2009
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
Current treatment used to treat all migraine headaches
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Upland, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Primary Completion
February 2006
Actual (reported)Study Completion
February 2006
Actual (reported)Last Updated
February 15, 2010
Record last verified: 2010-02
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Source: ClinicalTrials.gov.
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