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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment Sequence A	rizatriptan	Rizatriptan - Rizatriptan - Placebo
Treatment Sequence B	rizatriptan	Rizatriptan - Placebo - Rizatriptan
Treatment Sequence C	rizatriptan	Placebo - Rizatriptan - Rizatriptan

Primary Outcome Measures

Name	Time	Method
Pain Relief (PR)	2 hours post dose	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.

Secondary Outcome Measures

Name	Time	Method
Pain Freedom (PF)	2 hours post dose	Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.