Status:
COMPLETED
Treatment of Multiple Attacks of Acute Migraine (0462-025)
Lead Sponsor:
Organon and Co
Conditions:
Migraine Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.
Eligibility Criteria
Inclusion
- Patient had at least a 6-month history of migraine, with or without aura
- Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
- Patient was judged to be in good health, apart from migraine
Exclusion
- Patient was pregnant or a nursing mother.
- Patient had abused drugs or alcohol within 12 months prior to entering the study
- Patient had a history of cardiovascular disease
- Patient had clinically significant ECG abnormality
- Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- Patient received treatment with an investigational device or compound within 30 days of the study start
- Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
- Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- Patient had prior exposure to rizatriptan
Key Trial Info
Start Date :
April 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1996
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00899379
Start Date
April 1 1995
End Date
April 1 1996
Last Update
February 3 2022
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