CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Erenumab +1 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/NCT01723514
NCT01723514Phase 1Completed
CompareCT.gov

Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and in Migraine Patients

Amgen·interventional·Posted Nov 8, 2012·Updated Jan 18, 2019

In Brief

A Phase 1 clinical trial evaluating Erenumab and Placebo for Migraine. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy adults and migraine patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2012
Enrollment StartNov 14, 2012
Primary CompletionJul 10, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago

Interventions

Erenumabdrug

Administered by subcutaneous injection once a month

Placebodrug

Administered by subcutaneous injection once a month