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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.
August 13, 2007
August 15, 2007
March 12, 2009
April 14, 2009
June 9, 2017
October 3, 2007
April 8, 2008   (Final data collection date for primary outcome measure)
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.
  • Percentage of patients who are pain free [ Time Frame: 2 hours postdose ]
  • Tolerability as measured by subjective adverse experience reporting
Complete list of historical versions of study NCT00516737 on ClinicalTrials.gov Archive Site
  • 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.

Percentage of patients with 24hr sustained pain freedom, associated symptoms, and use of rescue medication [ Time Frame: 24hr post dose ]
Not Provided
Not Provided
 
Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)
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
The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Migraine
  • Drug: Comparator: rizatriptan benzoate
    Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
    Other Name: MK0462
  • Drug: Comparator: Placebo
    Matching placebo; one dose, treatment of a single migraine attack
  • Experimental: 1
    Active Drug
    Intervention: Drug: Comparator: rizatriptan benzoate
  • Placebo Comparator: 2
    Matching Pbo Comparator
    Intervention: Drug: Comparator: Placebo
Cady RK, Martin VT, Géraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
April 8, 2008
April 8, 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Germany,   United States
 
NCT00516737
0462-081
2007_547
Not Provided
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP