Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00516737
First received: August 13, 2007
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.


Condition Intervention Phase
Migraine
Drug: Comparator: rizatriptan benzoate
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Are Pain Free at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.


Secondary Outcome Measures:
  • Number of Participants With 24-Hour Sustained Pain Freedom [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
    24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.

  • Number of Participants With no Rescue Use up to 24 Hours Post-Dose [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
    Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.

  • Number of Participants With Absence of Photophobia at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.

  • Number of Participants With Absence of Phonophobia at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.

  • Number of Participants With Absence of Nausea at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.

  • Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]

    Level of functional disability was assessed on a paper diary by the participants.

    Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.



Enrollment: 207
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active Drug
Drug: Comparator: rizatriptan benzoate
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Other Name: MK0462
Placebo Comparator: 2
Matching Pbo Comparator
Drug: Comparator: Placebo
Matching placebo; one dose, treatment of a single migraine attack

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than one year history of migraine
  • Attacks typically mild when they begin and progress to moderate or severe
  • Experience 1-4 migraine attacks per month

Exclusion Criteria:

  • More than 15 headache days per month
  • Heart disease
  • Uncontrolled high blood pressure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516737

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: NCT00516737     History of Changes
Other Study ID Numbers: 0462-081, 2007_547
Study First Received: August 13, 2007
Results First Received: March 12, 2009
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
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 April 21, 2014