Status:
COMPLETED
Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Menstrual Migraine (MM) Headaches
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00904098
Start Date
September 1 2005
End Date
February 1 2006
Last Update
February 15 2010
Active Locations (21)
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1
Stratford, Connecticut, United States
2
Clearwater, Florida, United States
3
Jacksonville, Florida, United States
4
Largo, Florida, United States