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Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
rizatriptan benzoate (5 mg)
rizatriptan benzoate (10 mg)
Rizatriptan 5 mg Placebo
Rizatriptan 10 mg Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
  • Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines
  • Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration

Exclusion Criteria:

  • Subject has no history of migraine headaches
  • Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)
  • Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Panel A Rizatriptan

    Panel A Placebo

    Panel B Rizatriptan

    Panel B Placebo

    Panel C Rizatriptan

    Panel C Placebo

    Arm Description

    Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A.

    Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A.

    Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B.

    Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B.

    Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.

    Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.

    Outcomes

    Primary Outcome Measures

    Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
    All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)

    Secondary Outcome Measures

    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))
    Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot
    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)
    Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved
    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)
    Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration
    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)
    Preliminary pharmacokinetics data; Apparent half-life (t½)

    Full Information

    First Posted
    October 17, 2007
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00604812
    Brief Title
    Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Single-Dose Pharmacokinetics of MK0462 in Subjects With Migraines Aged 6 to 17 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 17, 2007 (Actual)
    Primary Completion Date
    September 17, 2010 (Actual)
    Study Completion Date
    September 17, 2010 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines. After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Panel A Rizatriptan
    Arm Type
    Experimental
    Arm Description
    Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A.
    Arm Title
    Panel A Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A.
    Arm Title
    Panel B Rizatriptan
    Arm Type
    Experimental
    Arm Description
    Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B.
    Arm Title
    Panel B Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B.
    Arm Title
    Panel C Rizatriptan
    Arm Type
    Experimental
    Arm Description
    Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
    Arm Title
    Panel C Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
    Intervention Type
    Drug
    Intervention Name(s)
    rizatriptan benzoate (5 mg)
    Other Intervention Name(s)
    MAXALT®, MK0462
    Intervention Description
    A single dose of rizatriptan 5 mg administered on Day 1.
    Intervention Type
    Drug
    Intervention Name(s)
    rizatriptan benzoate (10 mg)
    Other Intervention Name(s)
    MAXALT®, MK0462
    Intervention Description
    A single dose of rizatriptan 10 mg administered on Day 1.
    Intervention Type
    Drug
    Intervention Name(s)
    Rizatriptan 5 mg Placebo
    Intervention Description
    A single dose of rizatriptan 5 mg placebo administered on Day 1.
    Intervention Type
    Drug
    Intervention Name(s)
    Rizatriptan 10 mg Placebo
    Intervention Description
    A single dose of rizatriptan 10 mg placebo administered on Day 1.
    Primary Outcome Measure Information:
    Title
    Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
    Description
    All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)
    Time Frame
    24 Hours
    Secondary Outcome Measure Information:
    Title
    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))
    Description
    Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot
    Time Frame
    24 Hours
    Title
    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)
    Description
    Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved
    Time Frame
    24 Hours
    Title
    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)
    Description
    Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration
    Time Frame
    24 Hours
    Title
    Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)
    Description
    Preliminary pharmacokinetics data; Apparent half-life (t½)
    Time Frame
    24 Hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration Exclusion Criteria: Subject has no history of migraine headaches Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI) Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    22289113
    Citation
    Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P. Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study. Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30.
    Results Reference
    derived

    Learn more about this trial

    Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)

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