Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2018-05-04
2021-11-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1
Subjects with a body weight at Day 1 of less than weight threshold.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Arkansas Childrens Hospital
Little Rock, Arkansas, United States
CarePoint
Englewood, Colorado, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Synergy Health
Bradenton, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
PANDA Neurology and Atlanta Headache Specialists
Atlanta, Georgia, United States
Riley Hosptial
Indianapolis, Indiana, United States
Clinical Research Institute Inc
Plymouth, Minnesota, United States
Childrens Mercy Hospital
Kansas City, Missouri, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Dent Neurosciences Research Center
Amherst, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Childrens Hospital
Columbus, Ohio, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20160172
Identifier Type: -
Identifier Source: org_study_id
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