ClinicalTrials.gov
ClinicalTrials.gov Menu

AMG 334 20160172 Pediatric Migraine PK Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03499119
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
AMG 334 20160172 Pediatric Migraine PK Study.

Condition or disease Intervention/treatment Phase
Migraine Drug: AMG 334 Dose 1 Drug: AMG 334 Dose 2 Drug: AMG 334 Dose 3 Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : December 16, 2020
Estimated Study Completion Date : September 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Cohort 1
Subjects with a body weight at Day 1 of less than weight threshold.
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 weighting weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2


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

Cohort 2
Subjects with a body weight at Day 1 of weight threshold or more.
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 weighting weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2


Drug: AMG 334 Dose 2
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.




Primary Outcome Measures :
  1. Serum PK parameter of AMG 334 time to maximum observed concentration [Cmax] [ Time Frame: 52 weeks ]
  2. Serum PK parameter of AMG 334 time to maximum concentration [tmax] [ Time Frame: 52 weeks ]
  3. Serum PK parameter of AMG 334 area under the concentration time cure from 0 to 28 days [AUC 0-28days] [ Time Frame: 28 days ]
  4. Serum PK parameter of AMG 334 area under concentration time curve [AUC] [ Time Frame: 52 weeks ]
  5. Serum PK parameter of AMG 334 time to trough concentration [Ctrough] [ Time Frame: 52 weeks ]
  6. Treatment-emergent adverse events [ Time Frame: 52 weeks ]
  7. Heart Rate [ Time Frame: 52 Weeks ]
  8. Body Temperature [ Time Frame: 52 Weeks ]
  9. Blood Pressure [ Time Frame: 52 Weeks ]
  10. Duration and morphology of P, QRS and T waves in 12-lead electrocardiograms (ECGs) [ Time Frame: 52 weeks ]
  11. Standard Hematology Lab Assessments [ Time Frame: 52 Weeks ]
  12. Standard Chemistry [ Time Frame: 52 Weeks ]
    Including liver function

  13. Standard sensory assessment of body and peripheral and central nervous systems [ Time Frame: 52 Weeks ]
  14. Standard motor assessment of body peripheral and central nervous systems [ Time Frame: 52 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499119


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
United States, Arkansas
Research Site Recruiting
Little Rock, Arkansas, United States, 72202
United States, Florida
Research Site Recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30328
United States, Minnesota
Research Site Recruiting
Plymouth, Minnesota, United States, 55441
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03499119     History of Changes
Other Study ID Numbers: 20160172
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.amgen.com/datasharing

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases