A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

• Status: Completed
• Trial end date: 2010-01-12
• Target enrollment: 0
• Participant gender: All

Summary

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

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

Details

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

Criteria

Inclusion Criteria:

• Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month

• Patient generally does not respond to treatment with sumatriptan

• Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study

• Patient is able to complete paper diary

Exclusion Criteria:

• Patient is pregnant or breast feeding or excepts to become pregnant during the study

• Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours

• Patient has basilar or hemiplegic migraines

• Patient is unable to distinguish between migraine attacks from other types of headaches

• Patient has more than 15 headache-days per month

• Patient was greater than 50 years old at age of migraine onset

• Patient has failed to respond to 3 or more triptans

• Patient has a repeated history of failing to respond to or tolerate rizatriptan

• Patient uses opioids as primary migraine therapy

• Patient uses daily opioids

• Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease

• Patient has uncontrolled hypertension

• Patient has a history of neoplastic disease

• Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening

• Patient has a history of drug or alcohol abuse