Status:
COMPLETED
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
Lead Sponsor:
Organon and Co
Conditions:
Migraine Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.
Eligibility Criteria
Inclusion
- Participant had at least a 6-month history of migraine, with or without aura
- Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
- Participant was judged to be in good health, apart from migraine
Exclusion
- Participant was Pregnant or a nursing mother
- Participant had a history or current evidence of drug or alcohol abuse
- Participant had a history or clinical evidence of cardiovascular disease
- Participant had a clinically significant Electrocardiography (ECG) abnormality
- Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- Participant had received treatment with an investigational device or compound within 30 days of the study
- Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
- Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
Key Trial Info
Start Date :
August 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1996
Estimated Enrollment :
933 Patients enrolled
Trial Details
Trial ID
NCT00897104
Start Date
August 1 1995
End Date
September 1 1996
Last Update
February 3 2022
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