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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00897949
First received: May 8, 2009
Last updated: September 3, 2014
Last verified: September 2014
  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 Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897949

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00897949     History of Changes
Other Study ID Numbers: 0462-022, 2009_589
Study First Received: May 8, 2009
Results First Received: September 26, 2009
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Recurrence
Brain Diseases
Central Nervous System Diseases
Disease Attributes
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Pathologic Processes
Rizatriptan
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on October 29, 2014