A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

October 3, 2022 updated by: Amgen

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention

To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy.

Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).

Study Type

Interventional

Enrollment (Actual)

667

Phase

  • Phase 2

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M 1M4
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Research Site
  • Czechia
      • Brno, Czechia, 656 91
        • Research Site
      • Brno, Czechia, 611 00
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 4, Czechia, 140 59
        • Research Site
  • Denmark
      • Glostrup, Denmark, 2600
        • Research Site
  • Finland
      • Helsinki, Finland, 00100
        • Research Site
      • Jyväskylä, Finland, 40100
        • Research Site
      • Oulu, Finland, 90101
        • Research Site
      • Tampere, Finland, 33100
        • Research Site
      • Turku, Finland, 20100
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Berlin, Germany, 10435
        • Research Site
      • Bochum, Germany, 44787
        • Research Site
      • Essen, Germany, 45147
        • Research Site
      • Hamburg, Germany, 20251
        • Research Site
      • Kiel, Germany, 24149
        • Research Site
      • Königstein im Taunus, Germany, 61462
        • Research Site
  • Norway
      • Lillehammar, Norway, 2629
        • Research Site
      • Sandvika, Norway, 1337
        • Research Site
      • Stavanger, Norway, 4005
        • Research Site
      • Ålesund, Norway, 6003
        • Research Site
  • Poland
      • Krakow, Poland, 31-209
        • Research Site
      • Lodz, Poland, 90-338
        • Research Site
      • Lublin, Poland, 20-016
        • Research Site
      • Poznan, Poland, 60-355
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Warszawa, Poland, 00-669
        • Research Site
      • Warszawa, Poland, 04-052
        • Research Site
  • Sweden
      • Falköping, Sweden, 521 37
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Stockholm, Sweden, 112 45
        • Research Site
      • Stockholm, Sweden, 114 33
        • Research Site
      • Vällingby, Sweden, 162 68
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Research Site
      • Hull, United Kingdom, HU3 2JZ
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Research Site
      • Stoke on Trent, United Kingdom, ST4 6QG
        • Research Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • San Francisco, California, United States, 94109
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
      • Sherman Oaks, California, United States, 91403
        • Research Site
      • Stanford, California, United States, 94305
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Orlando, Florida, United States, 32801
        • Research Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Research Site
      • West Palm Beach, Florida, United States, 33407
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Decatur, Georgia, United States, 30033
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Research Site
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Research Site
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Research Site
      • Worcester, Massachusetts, United States, 01605
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Research Site
      • Kalamazoo, Michigan, United States, 49009
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
      • Springfield, Missouri, United States, 65807
        • Research Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Research Site
    • New York
      • Amherst, New York, United States, 14226
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Dallas, Texas, United States, 75214
        • Research Site
      • Temple, Texas, United States, 76508
        • Research Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98195-6169
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • 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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
  • History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
  • ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
  • Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

  • History of cluster headache or hemiplegic migraine headache
  • Unable to differentiate migraine from other headaches
  • Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
  • Received botulinum toxinin head or neck region within 4 months prior to screening.
  • Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Drug: Placebo
Administered once a month subcutaneously by authorized investigational site study staff.
EXPERIMENTAL: Erenumab 70 mg
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Biological: Erenumab
Administered once a month subcutaneously by authorized investigational site study staff.
Other Names:
  • AMG 334
  • Aimovig™
PLACEBO_COMPARATOR: Erenumab 140 mg
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Biological: Erenumab
Administered once a month subcutaneously by authorized investigational site study staff.
Other Names:
  • AMG 334
  • Aimovig™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Monthly Migraine Days
Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.

The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week treatment phase - the number of migraine days during the 4-week baseline phase.
4-week baseline phase and the last 4 weeks of the 12-week treatment phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline
Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of treatment.

At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days
Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.
4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Change From Baseline in Cumulative Monthly Headache Hours
Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase

The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.

A qualified headache was defined as follows:

  • a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or
  • a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or
  • a headache of any duration for which acute headache treatment was administered.
4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Number of Participants With Adverse Events
Time Frame: From the first dose of study drug up to 16 weeks after the last dose (24 weeks)

Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:

Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE.
From the first dose of study drug up to 16 weeks after the last dose (24 weeks)
Number of Participants Who Developed Antibodies to Erenumab
Time Frame: Baseline and weeks 2, 4, 8, 12 and 24

Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).

Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.

If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
Baseline and weeks 2, 4, 8, 12 and 24

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)

March 5, 2014

Primary Completion (ACTUAL)

February 24, 2016

Study Completion (ACTUAL)

April 28, 2016

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (ESTIMATE)

February 19, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120295
  • 2013-001707-36 (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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