search
Back to results

Treatment of Multiple Attacks of Acute Migraine (0462-025)

Primary Purpose

Migraine Headache

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rizatriptan benzoate
Comparator: Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Treatment Sequence 1

    Treatment Sequence 2

    Treatment Sequence 3

    Treatment Sequence 4

    Treatment Sequence 5

    Arm Description

    Placebo-Rizatriptan-Rizatriptan-Rizatriptan

    Rizatriptan-Placebo-Rizatriptan-Rizatriptan

    Rizatriptan-Rizatriptan-Placebo-Rizatriptan

    Rizatriptan-Rizatriptan-Rizatriptan-Placebo

    Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan

    Outcomes

    Primary Outcome Measures

    Pain Relief at 2 Hours During the First Migraine Attack Period
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack

    Secondary Outcome Measures

    Pain Relief at 2 Hours During the Second Migraine Attack Period
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack
    Pain Relief at 2 Hours During the Third Migraine Attack Period
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack
    Pain Relief at 2 Hours During the Fourth Migraine Attack Period
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack

    Full Information

    First Posted
    May 8, 2009
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00899379
    Brief Title
    Treatment of Multiple Attacks of Acute Migraine (0462-025)
    Official Title
    A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1995 (undefined)
    Primary Completion Date
    January 1996 (Actual)
    Study Completion Date
    April 1996 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine Headache

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    473 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Sequence 1
    Arm Type
    Experimental
    Arm Description
    Placebo-Rizatriptan-Rizatriptan-Rizatriptan
    Arm Title
    Treatment Sequence 2
    Arm Type
    Experimental
    Arm Description
    Rizatriptan-Placebo-Rizatriptan-Rizatriptan
    Arm Title
    Treatment Sequence 3
    Arm Type
    Experimental
    Arm Description
    Rizatriptan-Rizatriptan-Placebo-Rizatriptan
    Arm Title
    Treatment Sequence 4
    Arm Type
    Experimental
    Arm Description
    Rizatriptan-Rizatriptan-Rizatriptan-Placebo
    Arm Title
    Treatment Sequence 5
    Arm Type
    Experimental
    Arm Description
    Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan
    Intervention Type
    Drug
    Intervention Name(s)
    rizatriptan benzoate
    Other Intervention Name(s)
    MK0462
    Intervention Description
    Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo to Rizatriptan, Oral Tablet
    Primary Outcome Measure Information:
    Title
    Pain Relief at 2 Hours During the First Migraine Attack Period
    Description
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Pain Relief at 2 Hours During the Second Migraine Attack Period
    Description
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack
    Time Frame
    2 hours
    Title
    Pain Relief at 2 Hours During the Third Migraine Attack Period
    Description
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack
    Time Frame
    2 hours
    Title
    Pain Relief at 2 Hours During the Fourth Migraine Attack Period
    Description
    Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19222588
    Citation
    Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.
    Results Reference
    background
    PubMed Identifier
    19210513
    Citation
    Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.
    Results Reference
    background
    PubMed Identifier
    9748025
    Citation
    Kramer MS, Matzura-Wolfe D, Polis A, Getson A, Amaraneni PG, Solbach MP, McHugh W, Feighner J, Silberstein S, Reines SA. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Rizatriptan Multiple Attack Study Group. Neurology. 1998 Sep;51(3):773-81. doi: 10.1212/wnl.51.3.773.
    Results Reference
    result
    PubMed Identifier
    11284464
    Citation
    Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x.
    Results Reference
    result

    Learn more about this trial

    Treatment of Multiple Attacks of Acute Migraine (0462-025)

    We'll reach out to this number within 24 hrs