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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00604812
First received: October 17, 2007
Last updated: September 26, 2014
Last verified: September 2014

October 17, 2007
September 26, 2014
December 2007
September 2010   (final data collection date for primary outcome measure)
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs [ Time Frame: 24 Hours ] [ Designated as safety issue: Yes ]
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)
To assess the safety and tolerability of single doses of MK0462 in pediatric migraineurs [ Time Frame: 5 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00604812 on ClinicalTrials.gov Archive Site
  • Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞)) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    Preliminary pharmacokinetics data; Apparent half-life (t½)
To obtain preliminary pharmacokinetic data following single dose administration of MK0462 [ Time Frame: 5 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine Disorders
  • Drug: rizatriptan benzoate (5 mg)
    A single dose of rizatriptan 5 mg administered on Day 1.
    Other Names:
    • MAXALT®
    • MK0462
  • Drug: rizatriptan benzoate (10 mg)
    A single dose of rizatriptan 10 mg administered on Day 1.
    Other Names:
    • MAXALT®
    • MK0462
  • Drug: Rizatriptan 5 mg Placebo
    A single dose of rizatriptan 5 mg placebo administered on Day 1.
  • Drug: Rizatriptan 10 mg Placebo
    A single dose of rizatriptan 10 mg placebo administered on Day 1.
  • Experimental: Panel A Rizatriptan

    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.

    Intervention: Drug: rizatriptan benzoate (5 mg)
  • Placebo Comparator: Panel A Placebo

    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.

    Intervention: Drug: Rizatriptan 5 mg Placebo
  • Experimental: Panel B Rizatriptan

    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.

    Intervention: Drug: rizatriptan benzoate (10 mg)
  • Placebo Comparator: Panel B Placebo

    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.

    Intervention: Drug: Rizatriptan 10 mg Placebo
  • Experimental: Panel C Rizatriptan

    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.

    Interventions:
    • Drug: rizatriptan benzoate (5 mg)
    • Drug: rizatriptan benzoate (10 mg)
  • Placebo Comparator: Panel C Placebo

    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.

    Interventions:
    • Drug: Rizatriptan 5 mg Placebo
    • Drug: Rizatriptan 10 mg Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00604812
0462-083, 2007_601
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

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