AMG 334 20160172 Pediatric Migraine PK Study.

NCT03499119 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20160172
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 14

Brief Summary

AMG 334 20160172 Pediatric Migraine PK Study.

Conditions

Migraine

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Cohort 1

OTHER

Subjects with a body weight at Day 1 of less than weight threshold.

Drug: AMG 334 Dose 1; Drug: AMG 334 Dose 3

Cohort 2

OTHER

Subjects with a body weight at Day 1 of weight threshold or more.

Drug: AMG 334 Dose 1; Drug: AMG 334 Dose 2

Interventions

AMG 334 Dose 1 DRUG

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

Cohort 1; Cohort 2

AMG 334 Dose 2 DRUG

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

Cohort 2

AMG 334 Dose 3 DRUG

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

Cohort 1

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (14)

Arkansas Childrens Hospital

Little Rock, Arkansas, 72202, United States

Location

CarePoint

Englewood, Colorado, 80112, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Synergy Health

Bradenton, Florida, 34208, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

PANDA Neurology and Atlanta Headache Specialists

Atlanta, Georgia, 30328, United States

Location

Riley Hosptial

Indianapolis, Indiana, 46202, United States

Location

Clinical Research Institute Inc

Plymouth, Minnesota, 55441, United States

Location

Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Meridian Clinical Research

Hastings, Nebraska, 68901, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Childrens Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 38476099 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

Amelogenin

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dental Enamel Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 17, 2018
• Study Start: May 4, 2018
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: May 28, 2024
• Results First Posted: March 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (14)