AMG 334 20160172 Pediatric Migraine PK Study.

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

AMG 334 20160172 Pediatric Migraine PK Study.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: AMG 334 Dose 1; Drug: AMG 334 Dose 3; Drug: AMG 334 Dose 2

Detailed Description

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
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Childrens Hospital
  • Colorado
    • Englewood, Colorado, United States, 80112
      • CarePoint
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Clinical Research
  • Florida
    • Bradenton, Florida, United States, 34208
      • Synergy Health
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • PANDA Neurology and Atlanta Headache Specialists
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hosptial
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute Inc
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Childrens Mercy Hospital
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; Subjects with a body weight at Day 1 of less than weight threshold.	Drug: AMG 334 Dose 1; 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; Drug: AMG 334 Dose 3; Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
Other: Cohort 2; Subjects with a body weight at Day 1 of weight threshold or more.	Drug: AMG 334 Dose 1; 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; Drug: AMG 334 Dose 2; Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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	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.	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.	Up to Week 52 + 16-week safety follow-up
Number of Participants With Clinically Significant Changes in Vital Signs Measurements	The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.	Up to Week 52 + 16-week safety follow-up
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements	Clinically significant changes in ECG was defined as incidence of abnormal ECG diagnosis based on 12-lead ECG including heart rate, QRS, QTc and PR intervals.	Up to Week 52
Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests	The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.	Up to Week 52 + 16-week safety follow-up
Number of Participants With Clinically Significant Changes in Neurological Assessments	The neurological examinations were completed as per standard of care.	Up to Week 52 + 16-week safety follow-up

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• Hershey AD, Paiva da Silva Lima G, Pannacciulli N, Mackowski M, Koukakis R, McVige JW. Pharmacokinetics and safety of erenumab in pediatric patients with migraine: A phase I, randomized, open-label, multiple-dose study. Clin Transl Sci. 2024 Mar;17(3):e13755. doi: 10.1111/cts.13755.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2018
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: 20160172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No