AMG 334 20160172 Pediatric Migraine PK Study.

• Status: Recruiting
• Trial end date: 2022-06-26
• Target enrollment: 0
• Participant gender: All

Summary

AMG 334 20160172 Pediatric Migraine PK Study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Erenumab

Criteria

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.