Phase 1 N=31 Randomized Double-blind Treatment

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

Migraine Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00604812 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2009

Primary outcome: Primary: Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs — 0; 0; 0; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: rizatriptan benzoate (5 mg) (Drug); rizatriptan benzoate (10 mg) (Drug); Rizatriptan 5 mg Placebo (Drug); Rizatriptan 10 mg Placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs	0; 0; 0; 3; 7; 3	—
SECONDARY Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))	59.4; 84.0; 67.93	—
SECONDARY Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)	24.6; 25.0; 18.4	—
SECONDARY Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)	1.0; 1.5; 1.3	—
SECONDARY Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)	1.3; 1.6; 1.6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00604812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.