AMG 334 20160172 Pediatric Migraine PK Study.

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499119
• Other study ID #: 20160172
• Status: Completed
• Phase: Phase 1
• Start date: May 4, 2018
• Est. completion date: November 23, 2021

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

AMG 334 20160172 Pediatric Migraine PK Study.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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
• AMG 334 Dose 2
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.
• AMG 334 Dose 3
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.

Locations

Country	Name	City	State
United States	Dent Neurosciences Research Center	Amherst	New York
United States	PANDA Neurology and Atlanta Headache Specialists	Atlanta	Georgia
United States	Synergy Health	Bradenton	Florida
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Childrens Hospital	Columbus	Ohio
United States	CarePoint	Englewood	Colorado
United States	Meridian Clinical Research	Hastings	Nebraska
United States	Riley Hosptial	Indianapolis	Indiana
United States	Childrens Mercy Hospital	Kansas City	Missouri
United States	Arkansas Childrens Hospital	Little Rock	Arkansas
United States	Clinical Research Institute Inc	Plymouth	Minnesota
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	State University of New York Upstate Medical University	Syracuse	New York
United States	Premiere Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   AmgenTrials clinical trials website