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

Organon and Co1,473 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,473

Conditions

Migraine Headache

Interventions

rizatriptan benzoate (MK0462)DRUG

Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.

Comparator: placeboDRUG

Placebo to rizatriptan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain Relief at 2 Hours After the 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.

Time frame: 2 hours after initial dose of test drug

Secondary Outcomes

Pain Free at 2 Hours After the 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.

Time frame: 2 hours after initial dose of test drug

No Disability at 2 Hours After the 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

Time frame: 2 hours after initial dose of test drug

Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug

Time frame: 2 hours after initial dose of test drug

Pain Relief 2 Hours After Treatment for Headache 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).

Time frame: 2 hours after treatment for recurrence

Data from ClinicalTrials.gov

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