A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
Abstract
AMG 334 20160172 Pediatric Migraine PK Study.
Conditions: Migraine.
Primary outcome: Time to Maximum Concentration (Tmax) of Erenumab; Maximum Observed Concentration (Cmax) of Erenumab; Trough Concentration (Ctrough) of Erenumab; Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab; Number of Participants With Treatment-emergent Adverse Events (TEAEs); Number of Participants With Clinically Significant Changes in Vital Signs Measurements; Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements; Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests; Number of Participants With Clinically Significant Changes in Neurological Assessments.
Enrollment: 53 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 53 participants or records.
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