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

October 3, 2022 updated by: Amgen

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week baseline phase); the double-blind treatment phase (24 weeks) in which participants received placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28 weeks); and a safety follow-up phase (12 weeks).

Study Type

Interventional

Enrollment (Actual)

955

Phase

  • Phase 3

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

  • Austria
      • Innsbruck, Austria, 6020
        • Research Site
      • Linz, Austria, 4020
        • Research Site
      • Wien, Austria, 1130
        • Research Site
      • Wien, Austria, 1090
        • Research Site
  • Belgium
      • Brussel, Belgium, 1090
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Hasselt, Belgium, 3500
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
      • Lodelinsart, Belgium, 6042
        • Research Site
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Research Site
      • Markham, Ontario, Canada, L3R 9X3
        • Research Site
      • Ottawa, Ontario, Canada, K2G 6E2
        • Research Site
    • Quebec
      • Levis, Quebec, Canada, G6W 0M5
        • Research Site
  • Czechia
      • Brno, Czechia, 656 91
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Pardubice, Czechia, 530 02
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 4, Czechia, 140 59
        • Research Site
  • Finland
      • Helsinki, Finland, 00100
        • Research Site
      • Kuopio, Finland, 70210
        • Research Site
      • Oulu, Finland, 90220
        • Research Site
      • Turku, Finland, 20100
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Berlin, Germany, 10435
        • Research Site
      • Berlin (Hellersdorf), Germany, 12627
        • Research Site
      • Bochum, Germany, 44787
        • Research Site
      • Frankfurt am Main, Germany, 60596
        • Research Site
      • Hamburg, Germany, 20249
        • Research Site
      • Hamburg, Germany, 20251
        • Research Site
      • Hüttenberg, Germany, 35652
        • Research Site
      • Kiel, Germany, 24149
        • Research Site
      • Köln, Germany, 50935
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Leipzig, Germany, 04107
        • Research Site
      • München, Germany, 81377
        • Research Site
      • Wiesbaden, Germany, 65191
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Research Site
  • Poland
      • Krakow, Poland, 31-505
        • 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, 02-097
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • Research Site
      • Komarno, Slovakia, 945 75
        • Research Site
      • Lucenec, Slovakia, 984 39
        • Research Site
  • Sweden
      • Falköping, Sweden, 521 37
        • Research Site
      • Helsingborg, Sweden, 252 21
        • Research Site
      • Stockholm, Sweden, 112 45
        • Research Site
      • Stockholm, Sweden, 114 33
        • Research Site
      • Uddevalla, Sweden, 451 50
        • Research Site
  • Turkey
      • Adana, Turkey, 1330
        • Research Site
      • Ankara, Turkey, 06500
        • Research Site
      • Antalya, Turkey, 07058
        • Research Site
      • Bursa, Turkey, 16059
        • Research Site
      • Istanbul, Turkey, 34098
        • Research Site
      • Istanbul, Turkey, 34384
        • Research Site
      • Izmir, Turkey, 35040
        • Research Site
      • Izmir, Turkey, 35340
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Research Site
      • Liverpool, United Kingdom, L9 7AL
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Research Site
      • London, United Kingdom, RM1 3PJ
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Oxford, United Kingdom, OX3 9DU
        • Research Site
      • Sidcup, United Kingdom, DA14 6LT
        • Research Site
      • Stoke on Trent, United Kingdom, ST4 6QG
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Encino, California, United States, 91316
        • Research Site
      • Irvine, California, United States, 92618
        • Research Site
      • Los Alamitos, California, United States, 90720
        • Research Site
      • Newport Beach, California, United States, 92660
        • Research Site
      • Rancho Mirage, California, United States, 92270
        • Research Site
      • Redlands, California, United States, 92374
        • Research Site
      • Sherman Oaks, California, United States, 91403
        • Research Site
      • Simi Valley, California, United States, 93065
        • Research Site
      • Spring Valley, California, United States, 91978
        • Research Site
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Research Site
    • Connecticut
      • East Hartford, Connecticut, United States, 06118
        • Research Site
      • Stamford, Connecticut, United States, 06905
        • Research Site
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Bradenton, Florida, United States, 34205
        • Research Site
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Leesburg, Florida, United States, 34748
        • Research Site
      • Miami, Florida, United States, 33135
        • Research Site
      • Ocala, Florida, United States, 34471
        • Research Site
      • Orlando, Florida, United States, 32801
        • Research Site
      • Sunrise, Florida, United States, 33351
        • Research Site
      • West Palm Beach, Florida, United States, 33407
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Research Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Research Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Research Site
      • Wichita, Kansas, United States, 67207
        • Research Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Research Site
      • New Orleans, Louisiana, United States, 70119
        • Research Site
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Research Site
      • Worcester, Massachusetts, United States, 01605
        • Research Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Research Site
      • Saint Louis, Missouri, United States, 63141
        • Research Site
      • Springfield, Missouri, United States, 65807
        • Research Site
    • New York
      • Amherst, New York, United States, 14226
        • Research Site
      • Plainview, New York, United States, 11803
        • Research Site
      • Rochester, New York, United States, 14609
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Research Site
      • Greensboro, North Carolina, United States, 27405
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Willoughby Hills, Ohio, United States, 44094
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Research Site
    • South Carolina
      • Port Royal, South Carolina, United States, 29935
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Research Site
      • Bedford, Texas, United States, 76022
        • Research Site
      • Irving, Texas, United States, 75039
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Research Site
      • West Jordan, Utah, United States, 84088
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • 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 migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification
  • Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline
  • Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline
  • Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

  • Older than 50 years of age at migraine onset
  • History of cluster headache or hemiplegic migraine headache
  • Unable to differentiate migraine from other headache
  • No therapeutic response with > 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
  • Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
  • Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Drug: Placebo
Administered by subcutaneous injection once a month
EXPERIMENTAL: Erenumab 70 mg QM
Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Drug: Erenumab
Administered by subcutaneous injection once a month
Other Names:
  • AMG 334
  • Aimovig™
EXPERIMENTAL: Erenumab 140 mg QM
Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Drug: Erenumab
Administered by subcutaneous injection once a month
Other Names:
  • AMG 334
  • Aimovig™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period
Time Frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind 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 average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days in the Last 3 Months of the Double-blind Treatment Phase
Time Frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind 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.

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 3 months (mean of months 4, 5 and 6) of the 24-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period
Time Frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind 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.

The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment phase - the number of migraine-specific treatment days during the 4-week baseline phase.
4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Mean Monthly Average Physical Impairment Domain Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
Time Frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.

Change from baseline was calculated as (mean monthly average physical impairment scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly average physical impairment scores as measured by the MPFID).
4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
Time Frame: 4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.

Change from baseline was calculated as (mean monthly impact on everyday activities scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly impact on everyday activities scores as measured by the MPFID).
4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

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)

July 17, 2015

Primary Completion (ACTUAL)

September 5, 2016

Study Completion (ACTUAL)

June 19, 2017

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (ESTIMATE)

May 28, 2015

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

  • 20120296
  • 2014-004464-38 (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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