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 |
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
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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