A Randomized, Triple-Blind, Double-Dummy, Placebo-Controlled, Parallel Groups, Outpatient Study to Examine the Safety and Efficacy of MK0462 10 mg p.o. and MK0462 5 mg p.o. for the Treatment of Acute Migraine and Migraine Recurrence
Overview
- Phase
- Phase 3
- Intervention
- rizatriptan benzoate (MK0462)
- Conditions
- Migraine Headache
- Sponsor
- Organon and Co
- Enrollment
- 1473
- Primary Endpoint
- Pain Relief at 2 Hours After the Initial Dose of Test Drug
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Rizatriptan 10 mg
Intervention: rizatriptan benzoate (MK0462)
Rizatriptan 5 mg
Intervention: rizatriptan benzoate (MK0462)
Outcomes
Primary Outcomes
Pain Relief at 2 Hours After the Initial Dose of Test Drug
Time Frame: 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 Outcomes
- 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)
- No Disability at 2 Hours After the Initial Dose of Test Drug(2 hours after initial dose of test drug)
- Pain Free at 2 Hours After the Initial Dose of Test Drug(2 hours after initial dose of test drug)