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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 : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date December 6, 2021
Actual Study Start Date  ICMJE May 4, 2018
Estimated Primary Completion Date April 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Serum PK parameter of AMG 334 maximum observed concentration [Cmax] [ Time Frame: 12 weeks for subjects completing initial treatment period ]
  • Serum PK parameter of AMG 334 time to maximum concentration [tmax] [ Time Frame: 12 weeks for subjects completing initial treatment period ]
  • 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 ]
  • 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 ]
  • Treatment-emergent adverse events [ Time Frame: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension ]
  • Heart Rate [ Time Frame: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension ]
  • Body Temperature [ Time Frame: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension ]
  • Blood Pressure [ Time Frame: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension ]
  • 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 ]
  • Standard Hematology Lab Assessments [ Time Frame: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension ]
  • Standard Chemistry [ Time Frame: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension ]
    Including liver function
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • Serum PK parameter of AMG 334 time to maximum observed concentration [Cmax] [ Time Frame: 52 weeks ]
  • Serum PK parameter of AMG 334 time to maximum concentration [tmax] [ Time Frame: 52 weeks ]
  • Serum PK parameter of AMG 334 area under the concentration time cure from 0 to 28 days [AUC 0-28days] [ Time Frame: 28 days ]
  • Serum PK parameter of AMG 334 area under concentration time curve [AUC] [ Time Frame: 52 weeks ]
  • Serum PK parameter of AMG 334 time to trough concentration [Ctrough] [ Time Frame: 52 weeks ]
  • Treatment-emergent adverse events [ Time Frame: 52 weeks ]
  • Heart Rate [ Time Frame: 52 Weeks ]
  • Body Temperature [ Time Frame: 52 Weeks ]
  • Blood Pressure [ Time Frame: 52 Weeks ]
  • Duration and morphology of P, QRS and T waves in 12-lead electrocardiograms (ECGs) [ Time Frame: 52 weeks ]
  • Standard Hematology Lab Assessments [ Time Frame: 52 Weeks ]
  • Standard Chemistry [ Time Frame: 52 Weeks ]
    Including liver function
  • Standard sensory assessment of body and peripheral and central nervous systems [ Time Frame: 52 Weeks ]
  • Standard motor assessment of body peripheral and central nervous systems [ Time Frame: 52 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 334 20160172 Pediatric Migraine PK Study.
Official Title  ICMJE A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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

  • Drug: AMG 334 Dose 2
    Subjects weighing 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.
Study Arms  ICMJE
  • Cohort 1
    Subjects with a body weight at Day 1 of less than weight threshold.
    Interventions:
    • Drug: AMG 334 Dose 1
    • Drug: AMG 334 Dose 3
  • Cohort 2
    Subjects with a body weight at Day 1 of weight threshold or more.
    Interventions:
    • Drug: AMG 334 Dose 1
    • Drug: AMG 334 Dose 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 26, 2022
Estimated Primary Completion Date April 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499119
Other Study ID Numbers  ICMJE 20160172
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP