AMG 334 20160172 Pediatric Migraine PK Study.



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:6 - 17
Updated:1/19/2019
Start Date:May 4, 2018
End Date:September 21, 2021
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

AMG 334 20160172 Pediatric Migraine PK Study.

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

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.
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