Phase 1
Completed N=31
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
Migraine Disorders
Source: ClinicalTrials.gov NCT00604812 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcomePrimary: Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs — 0; 0; 0; 3 Participants
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.
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 | — |
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
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. Informational only — not medical advice.