Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients

August 1, 2018 updated by: Amgen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy male and female subjects, as well as male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;

Exclusion Criteria:

- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erenumab
Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.
Drug: Erenumab
Administered by subcutaneous injection once a month
Other Names:
  • Aimovig™
  • AMG-334
Placebo Comparator: Placebo
Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.
Drug: Placebo
Administered by subcutaneous injection once a month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.

Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.

A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:

  • fatal
  • life-threatening (places the subject at immediate risk of death)
  • requires in-patient hospitalization or prolongation of existing hospitalization
  • results in persistent or significant disability/incapacity
  • congenital anomaly/birth defect
  • other medically important serious event.
From first dose of study drug until a maximum of 168 days after last dose (225 days)
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.
From first dose of study drug until a maximum of 168 days after last dose (225 days)
Number of Participants Who Developed Anti-erenumab Antibodies
Time Frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)

Participants who had a negative or no result at baseline and were antibody positive postbaseline.

Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.
From first dose of study drug until a maximum of 168 days after last dose (225 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Serum Concentration (Cmax) of Erenumab
Time Frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Time to Maximum Observed Concentration (Tmax) of Erenumab
Time Frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)
Time Frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Time Frame: Day 57 (assessed from predose to day 225))
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Day 57 (assessed from predose to day 225))
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Time Frame: Baseline, Days 8, 57, 85, 113, 169 and 197

Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.

Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.

According to the protocol, not all cohorts had dermal blood flow measurements at all time points.
Baseline, Days 8, 57, 85, 113, 169 and 197

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2012

Primary Completion (Actual)

July 10, 2014

Study Completion (Actual)

July 10, 2014

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 8, 2012

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101268
  • 2012-003594-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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