Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
1 other identifier
interventional
192
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2005
Shorter than P25 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 19, 2009
CompletedFebruary 15, 2010
February 1, 2010
5 months
May 15, 2009
February 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache pain severity
Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
Secondary Outcomes (6)
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)
- +1 more secondary outcomes
Study Arms (2)
Frovatriptan
EXPERIMENTALFrovatriptan 2.5 mg oral tablet
Usual Care
ACTIVE COMPARATORUsual care includes the current treatment used to treat all episodes of migraine headache
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Stratford, Connecticut, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Largo, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Blackwood, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Plainview, New York, United States
Unknown Facility
Vestal, New York, United States
Unknown Facility
Burlington, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Salisbury, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
West Chester, Ohio, United States
Unknown Facility
Norristown, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Saint Petersburg, Pennsylvania, United States
Unknown Facility
Upland, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Related Publications (1)
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.
PMID: 20236340DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sr. Director
Endo Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 19, 2009
Study Start
September 1, 2005
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
February 15, 2010
Record last verified: 2010-02