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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516737
First Posted: August 15, 2007
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]

    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
Actual Study Start Date: October 3, 2007
Study Completion Date: April 8, 2008
Primary Completion Date: April 8, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 13, 2007
First Posted: August 15, 2007
Results First Submitted: March 12, 2009
Results First Posted: April 14, 2009
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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