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

NCT00604812 | Completed Phase 1 Results

• 2 other identifiers: 0462-0832007_601
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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)

  24 Hours

Secondary Outcomes (4)

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

  24 Hours

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

  24 Hours

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

  24 Hours

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

  24 Hours

Study Arms (6)

Panel A Rizatriptan

EXPERIMENTAL

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.

Drug: rizatriptan benzoate (5 mg)

Panel A Placebo

PLACEBO COMPARATOR

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.

Drug: Rizatriptan 5 mg Placebo

Panel B Rizatriptan

EXPERIMENTAL

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.

Drug: rizatriptan benzoate (10 mg)

Panel B Placebo

PLACEBO COMPARATOR

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.

Drug: Rizatriptan 10 mg Placebo

Panel C Rizatriptan

EXPERIMENTAL

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.

Drug: rizatriptan benzoate (5 mg); Drug: rizatriptan benzoate (10 mg)

Panel C Placebo

PLACEBO COMPARATOR

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.

Drug: Rizatriptan 5 mg Placebo; Drug: Rizatriptan 10 mg Placebo

Interventions

rizatriptan benzoate (5 mg) DRUG

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

Also known as: MAXALT®, MK0462

Panel A Rizatriptan; Panel C Rizatriptan

rizatriptan benzoate (10 mg) DRUG

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

Also known as: MAXALT®, MK0462

Panel B Rizatriptan; Panel C Rizatriptan

Rizatriptan 5 mg Placebo DRUG

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

Panel A Placebo; Panel C Placebo

Rizatriptan 10 mg Placebo DRUG

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

Panel B Placebo; Panel C Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 22289113 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Pharmacokinetic data presented are preliminary data.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: January 30, 2008
• Study Start: December 17, 2007
• Primary Completion: September 17, 2010
• Study Completion: September 17, 2010
• Last Updated: April 19, 2024
• Results First Posted: September 2, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share