CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 53 enrolled
Drug / intervention
AMG 334 Dose 1 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03499119
NCT03499119Phase 1Completed

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

Amgen·interventional·Posted Apr 17, 2018·Updated May 28, 2024

In Brief

A Phase 1 clinical trial evaluating AMG 334 Dose 1, AMG 334 Dose 2, and 1 other intervention for Migraine. Completed, enrolled 53 participants across 14 sites.

Detailed Summary

AMG 334 20160172 Pediatric Migraine PK Study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 17, 2018
Enrollment StartMay 4, 2018
Primary CompletionNov 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.2 years ago

Interventions

AMG 334 Dose 1drug

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

AMG 334 Dose 2drug

Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.

AMG 334 Dose 3drug

Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.