Status:
COMPLETED
A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
Lead Sponsor:
Endo Pharmaceuticals
Collaborating Sponsors:
Vernalis (R&D) Ltd
Conditions:
Menstrually Associated Migraine
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objecti...
Eligibility Criteria
Inclusion
- Females aged 18 years and over
- 12 month or more documented history of menstrual migraine headache, according to International Headache Society classification
- An average frequency of MAM attacks in at lease 3 out of 4 menstrual cycles
- Regular predictable menstrual periods
- Able to accurately predict the onset of MAM headaches occurring between Day -2 and Day +4 of menses
- Able and willing to sign informed consent to comply with study procedures, including completion of diary cards
Exclusion
- More than three migraine attacks per month that were not MAM attacks
- Coronary artery disease including coronary vasospasm
- Significant cerebrovascular disease including basilar or hemiplegic migraine
- Uncontrolled hypertension
- Severe hepatic or renal insufficiency
- More than 15 headache days per month
- Any other condition or serious illness which would interfere with optimal participation in the study
- History of clinically relevant allergy, including that to frovatriptan or other triptans
- Pregnant or breast feeding or intending to become pregnant or to breast-feed during study period
- Participated in other frovatriptan menstrual migraine prevention studies
- Use of another investigation drug within 30 days or 5 half-lives (whichever is longer) before the screening visit
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
579 Patients enrolled
Trial Details
Trial ID
NCT00644033
Start Date
June 1 2001
End Date
June 1 2002
Last Update
January 2 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Endo Pharmaceuticals
Chadds Ford, Pennsylvania, United States, 19317