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

Primary Purpose

Migraine

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Erenumab

Placebo

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache, Prevention, Prophylaxis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Erenumab 70 mg QM

Erenumab 140 mg QM

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period

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.

Secondary Outcome Measures

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

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%.

Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period

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.

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

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).

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

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).

Full Information

NCT ID

NCT02456740

First Posted

May 14, 2015

Last Updated

October 3, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02456740

Brief Title

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

Acronym

STRIVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

July 17, 2015 (Actual)

Primary Completion Date

September 5, 2016 (Actual)

Study Completion Date

June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

Keywords

Migraine, Headache, Prevention, Prophylaxis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

955 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Erenumab 70 mg QM

Arm Type

Experimental

Arm Description

Arm Title

Erenumab 140 mg QM

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Erenumab

Other Intervention Name(s)

AMG 334, Aimovig™

Intervention Description

Administered by subcutaneous injection once a month

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered by subcutaneous injection once a month

Primary Outcome Measure Information:

Title

Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period

Description

Time Frame

4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Secondary Outcome Measure Information:

Title

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

Description

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%.

Time Frame

4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Title

Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period

Description

Time Frame

4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Title

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

Description

Time Frame

4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

Title

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

Description

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).

Time Frame

4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Research Site

City

Encino

State/Province

California

ZIP/Postal Code

91316

Country

United States

Facility Name

Research Site

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

Research Site

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

Research Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

Research Site

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Research Site

City

Redlands

State/Province

California

ZIP/Postal Code

92374

Country

United States

Facility Name

Research Site

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Research Site

City

Simi Valley

State/Province

California

ZIP/Postal Code

93065

Country

United States

Facility Name

Research Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Research Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

Research Site

City

East Hartford

State/Province

Connecticut

ZIP/Postal Code

06118

Country

United States

Facility Name

Research Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Research Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Research Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Research Site

City

Leesburg

State/Province

Florida

ZIP/Postal Code

34748

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United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Research Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

Research Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

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United States

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Research Site

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Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

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United States

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Research Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

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United States

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Research Site

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Evansville

State/Province

Indiana

ZIP/Postal Code

47714

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United States

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Research Site

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Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

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United States

Facility Name

Research Site

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Research Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

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United States

Facility Name

Research Site

City

Edgewood

State/Province

Kentucky

ZIP/Postal Code

41017

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United States

Facility Name

Research Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

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United States

Facility Name

Research Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Research Site

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02740

Country

United States

Facility Name

Research Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

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United States

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Research Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

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United States

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Research Site

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Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

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United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

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United States

Facility Name

Research Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Research Site

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Research Site

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

Research Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Research Site

City

Willoughby Hills

State/Province

Ohio

ZIP/Postal Code

44094

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

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United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

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United States

Facility Name

Research Site

City

Cumberland

State/Province

Rhode Island

ZIP/Postal Code

02864

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United States

Facility Name

Research Site

City

Port Royal

State/Province

South Carolina

ZIP/Postal Code

29935

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United States

Facility Name

Research Site

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Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

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United States

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Research Site

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Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

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United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Research Site

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

Research Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75039

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

Research Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

Research Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22911

Country

United States

Facility Name

Research Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Research Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Research Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Research Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Research Site

City

Lodelinsart

ZIP/Postal Code

6042

Country

Belgium

Facility Name

Research Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3Z 2N6

Country

Canada

Facility Name

Research Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Research Site

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3R 9X3

Country

Canada

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2G 6E2

Country

Canada

Facility Name

Research Site

City

Levis

State/Province

Quebec

ZIP/Postal Code

G6W 0M5

Country

Canada

Facility Name

Research Site

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Research Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Research Site

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Research Site

City

Praha 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Research Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Research Site

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Research Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Research Site

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Research Site

City

Berlin (Hellersdorf)

ZIP/Postal Code

12627

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10435

Country

Germany

Facility Name

Research Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Research Site

City

Hüttenberg

ZIP/Postal Code

35652

Country

Germany

Facility Name

Research Site

City

Kiel

ZIP/Postal Code

24149

Country

Germany

Facility Name

Research Site

City

Köln

ZIP/Postal Code

50935

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04107

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Research Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Research Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Research Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

31-505

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

90-338

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-016

Country

Poland

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Research Site

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

Research Site

City

Komarno

ZIP/Postal Code

945 75

Country

Slovakia

Facility Name

Research Site

City

Lucenec

ZIP/Postal Code

984 39

Country

Slovakia

Facility Name

Research Site

City

Falköping

ZIP/Postal Code

521 37

Country

Sweden

Facility Name

Research Site

City

Helsingborg

ZIP/Postal Code

252 21

Country

Sweden

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

112 45

Country

Sweden

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

114 33

Country

Sweden

Facility Name

Research Site

City

Uddevalla

ZIP/Postal Code

451 50

Country

Sweden

Facility Name

Research Site

City

Adana

ZIP/Postal Code

1330

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Research Site

City

Antalya

ZIP/Postal Code

07058

Country

Turkey

Facility Name

Research Site

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34384

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Research Site

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Research Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

RM1 3PJ

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Research Site

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Research Site

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

Research Site

City

Sidcup

ZIP/Postal Code

DA14 6LT

Country

United Kingdom

Facility Name

Research Site

City

Stoke on Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30086681

Citation

Buse DC, Lipton RB, Hallstrom Y, Reuter U, Tepper SJ, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. Cephalalgia. 2018 Sep;38(10):1622-1631. doi: 10.1177/0333102418789072. Epub 2018 Aug 7.

Results Reference

background

Citation

Cheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.

Results Reference

background

PubMed Identifier

29171821

Citation

Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.

Results Reference

background

PubMed Identifier

35272533

Citation

Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.

Results Reference

background

PubMed Identifier

35137394

Citation

Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.

Results Reference

background

PubMed Identifier

34841526

Citation

McAllister PJ, Turner I, Reuter U, Wang A, Scanlon J, Klatt J, Chou DE, Paiva da Silva Lima G. Timing and durability of response to erenumab in patients with episodic migraine. Headache. 2021 Nov;61(10):1553-1561. doi: 10.1111/head.14233. Epub 2021 Nov 28.

Results Reference

background

PubMed Identifier

31707815

Citation

Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.

Results Reference

background

PubMed Identifier

31852816

Citation

Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18. Erratum In: Neurology. 2020 Jun 9;94(23):1052.

Results Reference

background

PubMed Identifier

34407654

Citation

Lipton RB, Dodick DW, Kudrow D, Reuter U, Tenenbaum N, Zhang F, Lima GPDS, Chou DE, Mikol DD. Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. Cephalalgia. 2021 Dec;41(14):1458-1466. doi: 10.1177/03331024211028966. Epub 2021 Aug 18.

Results Reference

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PubMed Identifier

33315334

Citation

Yucel A, Thach A, Kumar S, Loden C, Bensink M, Goldfarb N. Estimating the economic burden of migraine on US employers. Am J Manag Care. 2020 Dec 1;26(12):e403-e408. doi: 10.37765/ajmc.2020.88547.

Results Reference

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PubMed Identifier

35978286

Citation

Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.

Results Reference

derived

PubMed Identifier

34928306

Citation

Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.

Results Reference

derived

PubMed Identifier

34301173

Citation

Tepper SJ, Ashina M, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Picard H, Cheng S, Chou DE, Zhang F, Klatt J, Mikol DD. Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials. J Headache Pain. 2021 Jul 23;22(1):81. doi: 10.1186/s10194-021-01292-w.

Results Reference

derived

PubMed Identifier

33939497

Citation

Diener HC, Ashina M, Ritter S, Paiva Da Silva Lima G, Rasmussen S, Zielman R, Tfelt-Hansen P. Erenumab prevents the occurrence of migraine attacks and not just migraine days: Post-hoc analyses of a phase III study. Cephalalgia. 2021 Oct;41(11-12):1262-1267. doi: 10.1177/03331024211010308. Epub 2021 May 3.

Results Reference

derived

PubMed Identifier

32851644

Citation

Broessner G, Reuter U, Bonner JH, Dodick DW, Hallstrom Y, Picard H, Zhang F, Lenz RA, Klatt J, Mikol DD. The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving >/=50%, >/=75%, and 100% Response. Headache. 2020 Oct;60(9):2026-2040. doi: 10.1111/head.13929. Epub 2020 Aug 26.

Results Reference

derived

PubMed Identifier

32746775

Citation

Pavlovic JM, Paemeleire K, Gobel H, Bonner J, Rapoport A, Kagan R, Zhang F, Picard H, Mikol DD. Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain. 2020 Aug 3;21(1):95. doi: 10.1186/s10194-020-01167-6.

Results Reference

derived

PubMed Identifier

32636324

Citation

Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Wright IK, Chou DE, Klatt J, Picard H, Lenz RA, Mikol DD. One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study. Neurology. 2020 Aug 4;95(5):e469-e479. doi: 10.1212/WNL.0000000000010019. Epub 2020 Jul 7.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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

Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial