MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

Phase 3

Completed

Brief Summary: A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo.

The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Rizatriptan 10 mg	rizatriptan benzoate (MK0462)	-
Rizatriptan 5 mg	rizatriptan benzoate (MK0462)	-

Primary Outcome Measures

Name	Time	Method
Pain Relief at 2 Hours After the Initial Dose of Test Drug	2 hours after initial dose of test drug	Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.

Secondary Outcome Measures

Name	Time	Method
Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug	2 hours after initial dose of test drug
Pain Relief 2 Hours After Treatment for Headache Recurrence	2 hours after treatment for recurrence	Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).
No Disability at 2 Hours After the Initial Dose of Test Drug	2 hours after initial dose of test drug	Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 - Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest
Pain Free at 2 Hours After the Initial Dose of Test Drug	2 hours after initial dose of test drug	Patients reporting pain free (defined as a reduction of headache severity to grade 0 \[no pain\]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.