MK0462 in Treatment of Migraine With Recurrence (MK0462-022)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00897949
First received: May 8, 2009
Last updated: April 5, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Headache |
Drug: rizatriptan benzoate (MK0462) Drug: Comparator: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Pain Relief at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ] [ Designated as safety issue: No ]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:
- Pain Free at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ] [ Designated as safety issue: No ]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.
- No Disability at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ] [ Designated as safety issue: No ]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
- Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug [ Time Frame: 2 hours after initial dose of test drug ] [ Designated as safety issue: No ]
- Pain Relief 2 Hours After Treatment for Headache Recurrence [ Time Frame: 2 hours after treatment for recurrence ] [ Designated as safety issue: No ]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).
| Enrollment: | 1473 |
| Study Start Date: | March 1995 |
| Study Completion Date: | July 1996 |
| Primary Completion Date: | January 1996 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rizatriptan 10 mg |
Drug: rizatriptan benzoate (MK0462)
Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.
|
| Experimental: Rizatriptan 5 mg |
Drug: rizatriptan benzoate (MK0462)
Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.
|
| Placebo Comparator: Placebo |
Drug: Comparator: placebo
Placebo to rizatriptan
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00897949 History of Changes |
| Other Study ID Numbers: | MK-0462-022, 2009_589 |
| Study First Received: | May 8, 2009 |
| Results First Received: | September 26, 2009 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Headache Recurrence Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Disease Attributes Pathologic Processes Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Benzoates Rizatriptan Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013