Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

• Status: Completed
• Trial end date: 1996-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Rizatriptan; Sumatriptan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 Electrocardiography (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 hypersensitivity to sumatriptan

• Patient had participated in any previous study involving rizatriptan