AMG 334 20160172 Pediatric Migraine PK Study.

Amgen

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: AMG 334 Dose 2; Drug: AMG 334 Dose 1; Drug: AMG 334 Dose 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT03499119

20160172

Details and patient eligibility

About

AMG 334 20160172 Pediatric Migraine PK Study.

Full description

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

Enrollment: 53 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

53 participants in 2 patient groups

Cohort 1

Other group

Description:

Subjects with a body weight at Day 1 of less than weight threshold.

Treatment:

Drug: AMG 334 Dose 3

Drug: AMG 334 Dose 1

Cohort 2

Other group

Description:

Subjects with a body weight at Day 1 of weight threshold or more.

Treatment:

Drug: AMG 334 Dose 1

Drug: AMG 334 Dose 2