AMG 334 20160172 Pediatric Migraine PK Study.
- Conditions
- Migraine
- Interventions
- Drug: AMG 334 Dose 1Drug: AMG 334 Dose 3Drug: AMG 334 Dose 2
- Registration Number
- NCT03499119
- Lead Sponsor
- Amgen
- Brief Summary
AMG 334 20160172 Pediatric Migraine PK Study.
- Detailed Description
An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 AMG 334 Dose 3 Subjects with a body weight at Day 1 of less than weight threshold. Cohort 2 AMG 334 Dose 1 Subjects with a body weight at Day 1 of weight threshold or more. Cohort 2 AMG 334 Dose 2 Subjects with a body weight at Day 1 of weight threshold or more. Cohort 1 AMG 334 Dose 1 Subjects with a body weight at Day 1 of less than weight threshold.
- Primary Outcome Measures
Name Time Method Time to Maximum Concentration (Tmax) of Erenumab 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.
Maximum Observed Concentration (Cmax) of Erenumab 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.
Trough Concentration (Ctrough) of Erenumab 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.
Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab 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.
Number of Participants With Clinically Significant Changes in Vital Signs Measurements Up to Week 52 + 16-week safety follow-up The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements 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.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests Up to Week 52 + 16-week safety follow-up The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.
Number of Participants With Clinically Significant Changes in Neurological Assessments Up to Week 52 + 16-week safety follow-up The neurological examinations were completed as per standard of care.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Arkansas Childrens Hospital
🇺🇸Little Rock, Arkansas, United States
CarePoint
🇺🇸Englewood, Colorado, United States
New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Synergy Health
🇺🇸Bradenton, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
PANDA Neurology and Atlanta Headache Specialists
🇺🇸Atlanta, Georgia, United States
Riley Hosptial
🇺🇸Indianapolis, Indiana, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Clinical Research Institute Inc
🇺🇸Plymouth, Minnesota, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Childrens Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Meridian Clinical Research
🇺🇸Hastings, Nebraska, United States
Nationwide Childrens Hospital
🇺🇸Columbus, Ohio, United States