AMG 334 20160172 Pediatric Migraine PK Study.

Completed · Phase 1

Conditions studied: Migraine

In brief

AMG 334 20160172 Pediatric Migraine PK Study.

Key facts

Study ID

NCT03499119

Run by

Amgen

People needed

53

Starts

2018-05-04

Expected to finish

2021-11-23

Last updated by the study team

2024-05-28

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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