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AMG 334 20160172 Pediatric Migraine PK Study.

Primary Purpose

Migraine

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 334 Dose 1
AMG 334 Dose 2
AMG 334 Dose 3
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arkansas Childrens Hospital
  • CarePoint
  • New England Institute for Clinical Research
  • Synergy Health
  • Premiere Research Institute
  • PANDA Neurology and Atlanta Headache Specialists
  • Riley Hosptial
  • Clinical Research Institute Inc
  • Childrens Mercy Hospital
  • Meridian Clinical Research
  • Dent Neurosciences Research Center
  • State University of New York Upstate Medical University
  • Cincinnati Childrens Hospital Medical Center
  • Nationwide Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cohort 1

Cohort 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum PK parameter of AMG 334 maximum observed concentration [Cmax]
Serum PK parameter of AMG 334 time to maximum concentration [tmax]
Serum PK parameter of AMG 334 area under the concentration time curve from 0 to 28 days [AUC 0-28days]
Serum PK parameter of AMG 334 trough concentration [Ctrough]
Treatment-emergent adverse events
Heart Rate
Body Temperature
Blood Pressure
Duration and morphology of P, QRS and T waves in 12-lead electrocardiograms (ECGs)
Standard Hematology Lab Assessments
Standard Chemistry
Including liver function
Standard sensory assessment of body and peripheral and central nervous systems
Standard motor assessment of body peripheral and central nervous systems

Secondary Outcome Measures

Full Information

First Posted
March 7, 2018
Last Updated
February 10, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03499119
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Per Amgen Regulatory and Study Team, the study can move forward with the close out activities for the PK study since all ongoing subjects have completed based.
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Other
Arm Description
Subjects with a body weight at Day 1 of less than weight threshold.
Arm Title
Cohort 2
Arm Type
Other
Arm Description
Subjects with a body weight at Day 1 of weight threshold or more.
Intervention Type
Drug
Intervention Name(s)
AMG 334 Dose 1
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
AMG 334 Dose 2
Intervention Description
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.
Intervention Type
Drug
Intervention Name(s)
AMG 334 Dose 3
Intervention Description
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
Primary Outcome Measure Information:
Title
Serum PK parameter of AMG 334 maximum observed concentration [Cmax]
Time Frame
12 weeks for subjects completing initial treatment period
Title
Serum PK parameter of AMG 334 time to maximum concentration [tmax]
Time Frame
12 weeks for subjects completing initial treatment period
Title
Serum PK parameter of AMG 334 area under the concentration time curve from 0 to 28 days [AUC 0-28days]
Time Frame
12 weeks for subjects completing initial treatment period
Title
Serum PK parameter of AMG 334 trough concentration [Ctrough]
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Treatment-emergent adverse events
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Heart Rate
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Body Temperature
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Blood Pressure
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Duration and morphology of P, QRS and T waves in 12-lead electrocardiograms (ECGs)
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Standard Hematology Lab Assessments
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Standard Chemistry
Description
Including liver function
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Standard sensory assessment of body and peripheral and central nervous systems
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension
Title
Standard motor assessment of body peripheral and central nervous systems
Time Frame
12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Childrens Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
CarePoint
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Synergy Health
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
PANDA Neurology and Atlanta Headache Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Riley Hosptial
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Clinical Research Institute Inc
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Childrens Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Childrens Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

AMG 334 20160172 Pediatric Migraine PK Study.

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