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

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: August 12, 2014
Last verified: August 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
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: 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: August 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
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 20, 2014