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Completed

NCT Number: NCT03499119

AMG 334 20160172 Pediatric Migraine PK Study.

AMG 334 20160172 Pediatric Migraine PK Study.

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Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arkansas Childrens Hospital, Little Rock, Arkansas, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

AMG 334 Dose 2

Drug

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

Primary outcomes

  1. Time to Maximum Concentration (Tmax) 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

    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.

  2. Maximum Observed Concentration (Cmax) 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

    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.

  3. 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

    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.

  4. 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

    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.

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

    Time frame: Up to Week 52 + 16-week safety follow-up

    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.

  6. Number of Participants With Clinically Significant Changes in Vital Signs Measurements

    Time frame: Up to Week 52 + 16-week safety follow-up

    The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.

  7. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements

    Time frame: Up to Week 52

    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.

  8. Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests

    Time frame: Up to Week 52 + 16-week safety follow-up

    The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.

  9. Number of Participants With Clinically Significant Changes in Neurological Assessments

    Time frame: Up to Week 52 + 16-week safety follow-up

    The neurological examinations were completed as per standard of care.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2018
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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