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MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

Primary Purpose

Migraine Headache

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rizatriptan benzoate (MK0462)
Comparator: sumatriptan
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:

  • Participant had at least a 6-month history of migraine, with or without aura
  • Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
  • Participant was judged to be in good health, apart from migraine

Exclusion Criteria:

  • Participant was Pregnant or a nursing mother
  • Participant had a history or current evidence of drug or alcohol abuse
  • Participant had a history or clinical evidence of cardiovascular disease
  • Participant had a clinically significant Electrocardiography (ECG) abnormality
  • Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
  • Participant had received treatment with an investigational device or compound within 30 days of the study
  • Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
  • Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
  • Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Rizatriptan

    Sumatriptan

    Placebo

    Outcomes

    Primary Outcome Measures

    Pain Relief at 2 Hours After Treatment
    Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
    Time to Relief Within 2 Hours After Treatment
    Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).

    Secondary Outcome Measures

    Pain Free at 2 Hours After Treatment
    Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
    Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
    Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).
    Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
    Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
    Participants Who Used Escape Medication 2 Hours After the Treatment Dose
    Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
    Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
    Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence

    Full Information

    First Posted
    May 8, 2009
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00897104
    Brief Title
    MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
    Official Title
    A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1995 (undefined)
    Primary Completion Date
    May 1996 (Actual)
    Study Completion Date
    September 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 compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.

    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
    933 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Rizatriptan
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Sumatriptan
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    rizatriptan benzoate (MK0462)
    Other Intervention Name(s)
    MK0462
    Intervention Description
    single dose 5 mg rizatriptan p.o.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: sumatriptan
    Intervention Description
    single dose 50 mg sumatriptan p.o.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
    Primary Outcome Measure Information:
    Title
    Pain Relief at 2 Hours After Treatment
    Description
    Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
    Time Frame
    2 hours after treatment
    Title
    Time to Relief Within 2 Hours After Treatment
    Description
    Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
    Time Frame
    within 2 hours after treatment
    Secondary Outcome Measure Information:
    Title
    Pain Free at 2 Hours After Treatment
    Description
    Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
    Time Frame
    2 hours after treatment
    Title
    Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
    Description
    Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).
    Time Frame
    2 hours after treatment
    Title
    Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
    Description
    Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
    Time Frame
    2 hours after treatment
    Title
    Participants Who Used Escape Medication 2 Hours After the Treatment Dose
    Description
    Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
    Time Frame
    2 hours after treatment
    Title
    Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
    Description
    Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence
    Time Frame
    24 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: Participant had at least a 6-month history of migraine, with or without aura Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions Participant was judged to be in good health, apart from migraine Exclusion Criteria: Participant was Pregnant or a nursing mother Participant had a history or current evidence of drug or alcohol abuse Participant had a history or clinical evidence of cardiovascular disease Participant had a clinically significant Electrocardiography (ECG) abnormality Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening Participant had received treatment with an investigational device or compound within 30 days of the study Participant typically suffered from less then 1 or more than 8 attacks of migraine per month Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
    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
    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
    11422095
    Citation
    Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x.
    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

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    MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

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