CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 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/NCT01688739
NCT01688739Phase 1Completed
CompareCT.gov

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

Amgen·interventional·Posted Sep 20, 2012·Updated Jan 18, 2019

In Brief

A Phase 1 clinical trial evaluating Erenumab and Placebo for Migraine. Completed, enrolled 61 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 single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants and migraine patients.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2012
Enrollment StartMar 13, 2012
Primary CompletionMar 27, 2013
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 13.8 years ago

Interventions

Erenumabdrug

Administered by subcutaneous injection or intravenous injection

Placebodrug

Administered by subcutaneous injection or intravenous injection