NCT03499119

AMG 334 20160172 Pediatric Migraine PK Study.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

AMG 334 20160172 Pediatric Migraine PK Study.

Detailed description

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

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	AMG 334 Dose 1	Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2
DRUG	AMG 334 Dose 2	Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.
DRUG	AMG 334 Dose 3	Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.

Timeline

• Start date: 2018-05-04
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2018-04-17
• Last updated: 2024-05-28
• Results posted: 2024-03-28

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study