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Completed

NCT Number: NCT00604812

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

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rizatriptan benzoate (5 mg)

Drug

A single dose of rizatriptan 5 mg administered on Day 1.

Other names: MAXALT®, MK0462

rizatriptan benzoate (10 mg)

Drug

A single dose of rizatriptan 10 mg administered on Day 1.

Other names: MAXALT®, MK0462

Rizatriptan 5 mg Placebo

Drug

A single dose of rizatriptan 5 mg placebo administered on Day 1.

Rizatriptan 10 mg Placebo

Drug

A single dose of rizatriptan 10 mg placebo administered on Day 1.

Primary outcomes

  1. Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs

    Time frame: 24 Hours

    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 outcomes

  1. Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))

    Time frame: 24 Hours

    Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot

  2. Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)

    Time frame: 24 Hours

    Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved

  3. Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)

    Time frame: 24 Hours

    Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration

  4. Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)

    Time frame: 24 Hours

    Preliminary pharmacokinetics data; Apparent half-life (t½)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 30, 2008
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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