Overview

Treatment of Multiple Attacks of Acute Migraine (0462-025)

Status:
Completed
Trial end date:
1996-04-01
Target enrollment:
0
Participant gender:
All
Summary
A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Rizatriptan
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 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