Clinical trial NCT03499119: AMG 334 20160172 Pediatric Migraine PK Study.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Maximum Concentration (Tmax) of Erenumab
timeFrame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
measure: Maximum Observed Concentration (Cmax) of Erenumab
timeFrame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
measure: Trough Concentration (Ctrough) of Erenumab
timeFrame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
measure: Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab
timeFrame: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 52 + 16-week safety follow-up
measure: Number of Participants With Clinically Significant Changes in Vital Signs Measurements
timeFrame: Up to Week 52 + 16-week safety follow-up
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
timeFrame: Up to Week 52
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests
timeFrame: Up to Week 52 + 16-week safety follow-up
measure: Number of Participants With Clinically Significant Changes in Neurological Assessments
timeFrame: Up to Week 52 + 16-week safety follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Childrens Hospital
state: Arkansas
city: Englewood
country: United States
facility: CarePoint
state: Colorado
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Bradenton
country: United States
facility: Synergy Health
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: PANDA Neurology and Atlanta Headache Specialists
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hosptial
state: Indiana
city: Plymouth
country: United States
facility: Clinical Research Institute Inc
state: Minnesota
city: Kansas City
country: United States
facility: Childrens Mercy Hospital
state: Missouri
city: Hastings
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Childrens Hospital
state: Ohio
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.