AMG 334 20160172 Pediatric Migraine PK Study.

Amgen53 enrolled

Overview

An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Migraine

Interventions

AMG 334 Dose 1DRUG

Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2

AMG 334 Dose 2DRUG

Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.

AMG 334 Dose 3DRUG

Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject's legally acceptable representative has provided informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. * Male and female children and adolescents ≥ 6 and \<18 years of age upon entry into screening * Diagnosis of migraines, with or without aura, according to the International Classification of Headache Disorders (ICHD 3rd Edition, 2013) for at least 12 months prior to the study screening * Frequency of migraine of ≥ 4 migraine days per month in each of the 3 months prior to the study screening period Exclusion Criteria: * Currently receiving treatment in another investigational device or drug study * History of migraine with brainstem aura or hemiplegic migraine headache * Medical history or other condition that compromises the ability of the subject or legally acceptable representative to give appropriate informed consent and/or assent * Malignancy except non-melanoma skin cancers or cervical cancer in situ within the last 5 years. * Presence of any clinical condition that in opinion of the investigator might increased the risk of subjects participating in the study.

Locations (14)

Arkansas Childrens Hospital

Little Rock, Arkansas, United States

CarePoint

Englewood, Colorado, United States

New England Institute for Clinical Research

Outcomes

Primary Outcomes

Time to Maximum Concentration (Tmax) of Erenumab

Blood samples for pharmacokinetic (PK) testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. Noncompartmental analysis (NCA) was performed for erenumab PK parameter estimation.

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Maximum Observed Concentration (Cmax) of Erenumab

Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Trough Concentration (Ctrough) of Erenumab

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab

Time frame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. A TEAE was defined as an AE starting on or after first dose of investigational product. The event did not necessarily have a causal relationship with study treatment.

Data from ClinicalTrials.gov

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