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

Primary Purpose

Migraine

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Erenumab

Placebo

Erenumab PFS

Erenumab AI/Pen

About this trial

This is an interventional prevention trial for Migraine focused on measuring migraine, headache, prevention, prophylaxis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of migraine for more than12 months prior to screening
Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase
Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase
Demonstrated at least 80% compliance with the eDiary during baseline phase

Exclusion Criteria:

Older than 50 years of age at migraine onset
History of cluster headache or basilar or hemiplegic migraine headache
Unable to differentiate migraine from other headaches
No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:
- Category 1: Divalproex sodium, sodium valproate
- Category 2: Topiramate
- Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
- Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
- Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran
- Category 6: Flunarizine, verapamil
- Category 7: Lisinopril, candesartan
- Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)
Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Erenumab 7 mg QM

Erenumab 21 mg QM

Erenumab 70 mg QM

CHU Substudy: Erenumab 140 mg PFS

CHU Substudy: Erenumab 140 mg AI/Pen

Arm Description

Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.

Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.

Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.

Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.

Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).

Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).

Outcomes

Primary Outcome Measures

Change From Baseline in Monthly Migraine Days at Week 12

CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab

To assess participants ability to administer a full dose of erenumab in home-use at day 29 (week 4) and day 57 (week 8), site staff called participants and asked whether the participant administered a full, partial, or no dose of erenumab. A full dose means that the entire volume of both prefilled syringes or autoinjector/pens were injected. Discontinued prior to dosing day indicates participants who had discontinued the investigational product and did not attempt to self-administer on day 29 or 57.

Secondary Outcome Measures

Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12

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 double-blind 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 double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.

Change From Baseline in Monthly Migraine Attacks at Week 12

A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack. The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine attacks during the 4-week baseline phase.

Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase

An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Mild; asymptomatic or mild symptoms Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care Life-threatening consequences; urgent intervention indicated Death related to AE A serious adverse event is an AE that meets at least 1 of the following criteria: fatal life threatening 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

Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase

CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy

AEs were graded using the CTCAE version 4.03: Mild; asymptomatic or mild symptoms Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care Life-threatening consequences; urgent intervention indicated Death related to AE A serious adverse event is an AE that meets at least 1 of the following criteria: fatal life threatening 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 An adverse device effect is any AE related to the use of a medical device, including AEs resulting from insufficient or inadequate instructions for use, any malfunction of the device, or use error or from intentional misuse of the device.

Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase

Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. Participants who developed anti-erenumab antibodies are participants who were negative or had no result at baseline but positive at any time postbaseline during the DBTP. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.

Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase

Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. Participants who developed anti-erenumab antibodies are participants who were negative prior to the first OLTP dose but positive at any time during the OLTP, or participants with no data prior to first dose in OLTP with any post-baseline positive results. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.

Full Information

NCT ID

NCT01952574

First Posted

August 30, 2013

Last Updated

October 3, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01952574

Brief Title

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

Official Title

A Phase 2, 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

August 6, 2013 (Actual)

Primary Completion Date

September 25, 2014 (Actual)

Study Completion Date

November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.

Detailed Description

The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 12-week double-blind treatment phase (DBTP), an open-label treatment phase (OLTP) for up to 256 weeks, and an 8-week safety follow-up (12 weeks after the last dose of investigational product [IP]). In the DBTP participants were to be randomized in a 3:2:2:2 ratio to placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg. During the open-label treatment phase, participants were to receive erenumab 70 mg QM from week 12 to week 264. After implementation of Protocol Amendment 3 (07 April 2016), participants remaining in the OLTP increased their dose to erenumab 140 mg QM up to week 264. The safety follow-up increased from an 8-week safety follow-up to a 12-week safety follow-up (16 weeks after the last dose of investigational product). During the OLTP participants enrolled at sites in the United States could enroll in an optional clinical home use (CHU) substudy, per a country-specific protocol amendment dated 20 June 2016. Participants in the CHU substudy were to be randomized 1:1 into 1 of 2 treatment groups: erenumab 140 mg using a prefilled syringe or erenumab 140 mg using an autoinjector/pen. Day 1 of the CHU substudy corresponded with any OLTP study visit up through Week 256, as long as the participant had received at least 2 doses of erenumab 140 mg. During the CHU substudy, participants initially self-administered IP under site supervision on substudy day 1, and then self-administered IP at home on substudy days 29 and 57.

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

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

In the DBTP participants were randomized to one of four arms. In the optional CHU substudy participants were randomized into one of two treatment groups.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

483 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Erenumab 7 mg QM

Arm Type

Experimental

Arm Description

Arm Title

Erenumab 21 mg QM

Arm Type

Experimental

Arm Description

Arm Title

Erenumab 70 mg QM

Arm Type

Experimental

Arm Description

Arm Title

CHU Substudy: Erenumab 140 mg PFS

Arm Type

Experimental

Arm Description

Arm Title

CHU Substudy: Erenumab 140 mg AI/Pen

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Erenumab

Other Intervention Name(s)

AMG 334, Aimovig™

Intervention Description

Administered by study site staff once a month (QM) as a subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered by study site staff once a month (QM) as a subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Erenumab PFS

Intervention Description

Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy

Intervention Type

Drug

Intervention Name(s)

Erenumab AI/Pen

Intervention Description

Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy

Primary Outcome Measure Information:

Title

Change From Baseline in Monthly Migraine Days at Week 12

Description

Time Frame

4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase

Title

CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab

Description

Time Frame

CHU substudy day 29 (week 4) and day 57 (week 8)

Secondary Outcome Measure Information:

Title

Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12

Description

Time Frame

4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase

Title

Change From Baseline in Monthly Migraine Attacks at Week 12

Description

Time Frame

4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase

Title

Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase

Description

Time Frame

From first dose of study drug in the double-blind treatment phase until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase.

Title

Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase

Description

Time Frame

From first dose in the open-label treatment phase up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; a maximum of 268 weeks.

Title

CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy

Description

Time Frame

From first dose in the CHU substudy to end of substudy (up to 12 weeks)

Title

Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase

Description

Time Frame

12 weeks

Title

Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase

Description

Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. Participants who developed anti-erenumab antibodies are participants who were negative prior to the first OLTP dose but positive at any time during the OLTP, or participants with no data prior to first dose in OLTP with any post-baseline positive results. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.

Time Frame

From week 12 up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of migraine for more than12 months prior to screening Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase Demonstrated at least 80% compliance with the eDiary during baseline phase Exclusion Criteria: Older than 50 years of age at migraine onset History of cluster headache or basilar or hemiplegic migraine headache Unable to differentiate migraine from other headaches No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are: Category 1: Divalproex sodium, sodium valproate Category 2: Topiramate Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol) Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline) Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran Category 6: Flunarizine, verapamil Category 7: Lisinopril, candesartan Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day) Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening

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

85032

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Research Site

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

Research Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Research Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

Research Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

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

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Research Site

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Research Site

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Research Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Research Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

Research Site

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32935

Country

United States

Facility Name

Research Site

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Research Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Research Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Research Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40513

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Research Site

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Research Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Research Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Research Site

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Research Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

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

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Research Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Research Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76017

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75214

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

Research Site

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Research Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Research Site

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Research Site

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Research Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Research Site

City

Mikkeli

ZIP/Postal Code

50100

Country

Finland

Facility Name

Research Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Research Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Research Site

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10409

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10435

Country

Germany

Facility Name

Research Site

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Facility Name

Research Site

City

Essen

ZIP/Postal Code

45133

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04107

Country

Germany

Facility Name

Research Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Research Site

City

Sandvika

ZIP/Postal Code

1337

Country

Norway

Facility Name

Research Site

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

Research Site

City

Ålesund

ZIP/Postal Code

6003

Country

Norway

Facility Name

Research Site

City

Falköping

ZIP/Postal Code

521 37

Country

Sweden

Facility Name

Research Site

City

Lund

ZIP/Postal Code

222 22

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

Vällingby

ZIP/Postal Code

162 68

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing URL

https://www.amgen.com/datasharing

Citations:

PubMed Identifier

26879279

Citation

Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M, Saper J, Cady R, Chon Y, Dietrich J, Lenz R. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):382-90. doi: 10.1016/S1474-4422(16)00019-3. Epub 2016 Feb 12.

Results Reference

background

PubMed Identifier

28835404

Citation

Ashina M, Dodick D, Goadsby PJ, Reuter U, Silberstein S, Zhang F, Gage JR, Cheng S, Mikol DD, Lenz RA. Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. Neurology. 2017 Sep 19;89(12):1237-1243. doi: 10.1212/WNL.0000000000004391. Epub 2017 Aug 23.

Results Reference

background

PubMed Identifier

31146544

Citation

Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick D, Rippon GA, Klatt J, Xue F, Chia V, Zhang F, Cheng S, Mikol DD. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019 Oct;39(11):1455-1464. doi: 10.1177/0333102419854082. Epub 2019 May 30.

Results Reference

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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

Migraine

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