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An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

NCT ID: NCT03308968

Last Updated: 2021-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

838 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2019-05-29

Brief Summary

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The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

Detailed Description

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Conditions

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Migraine Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Double-blind (DB) period: Participants with CM or EM will receive 3 injections of placebo 1.5 milliliters (mL) SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. Open-label (OL) period: Participants with CM or EM will receive fremanezumab (TEV-48125) 225 milligrams (mg) SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.

Group Type PLACEBO_COMPARATOR

Fremanezumab

Intervention Type DRUG

Fremanezumab will be administered per dose and schedule specified in the arm.

Placebo

Intervention Type DRUG

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Fremanezumab Quarterly

DB period: Participants with CM or EM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab will be administered per dose and schedule specified in the arm.

Placebo

Intervention Type DRUG

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Fremanezumab Monthly

DB period: Participants with CM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab will be administered per dose and schedule specified in the arm.

Placebo

Intervention Type DRUG

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Interventions

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Fremanezumab

Fremanezumab will be administered per dose and schedule specified in the arm.

Intervention Type DRUG

Placebo

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Intervention Type DRUG

Other Intervention Names

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TEV-48125

Eligibility Criteria

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Inclusion Criteria

* The participant has a diagnosis of migraine with onset at ≤50 years of age.
* Body weight ≥45 kilograms.
* The participant has a history of migraine for ≥12 months prior to screening.
* Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP)
* Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically \[that is; vasectomy\] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP).

* Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria

* At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.
* Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.
* The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.
* The participant uses triptans/ergots as preventive therapies for migraine.
* Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed.

* Additional criteria apply, please contact the investigator for more information.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 14742

Huntsville, Alabama, United States

Site Status

Teva Investigational Site 14729

Long Beach, California, United States

Site Status

Teva Investigational Site 14739

San Diego, California, United States

Site Status

Teva Investigational Site 14843

Santa Monica, California, United States

Site Status

Teva Investigational Site 14749

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 14758

Maitland, Florida, United States

Site Status

Teva Investigational Site 14738

Orlando, Florida, United States

Site Status

Teva Investigational Site 14760

Decatur, Georgia, United States

Site Status

Teva Investigational Site 14737

Meridian, Idaho, United States

Site Status

Teva Investigational Site 14730

Chicago, Illinois, United States

Site Status

Teva Investigational Site 14740

Evanston, Illinois, United States

Site Status

Teva Investigational Site 14735

Louisville, Kentucky, United States

Site Status

Teva Investigational Site 14747

Pikesville, Maryland, United States

Site Status

Teva Investigational Site 14750

Fall River, Massachusetts, United States

Site Status

Teva Investigational Site 14734

Watertown, Massachusetts, United States

Site Status

Teva Investigational Site 14731

Ann Arbor, Michigan, United States

Site Status

Teva Investigational Site 14748

Plymouth, Minnesota, United States

Site Status

Teva Investigational Site 14746

Omaha, Nebraska, United States

Site Status

Teva Investigational Site 14754

Berlin, New Jersey, United States

Site Status

Teva Investigational Site 14752

Albuquerque, New Mexico, United States

Site Status

Teva Investigational Site 14753

Amherst, New York, United States

Site Status

Teva Investigational Site 14736

Greensboro, North Carolina, United States

Site Status

Teva Investigational Site 14741

Greensboro, North Carolina, United States

Site Status

Teva Investigational Site 14732

Raleigh, North Carolina, United States

Site Status

Teva Investigational Site 14761

Lincoln, Rhode Island, United States

Site Status

Teva Investigational Site 14756

Warwick, Rhode Island, United States

Site Status

Teva Investigational Site 14745

Memphis, Tennessee, United States

Site Status

Teva Investigational Site 14743

Nashville, Tennessee, United States

Site Status

Teva Investigational Site 14733

Austin, Texas, United States

Site Status

Teva Investigational Site 14751

West Jordan, Utah, United States

Site Status

Teva Investigational Site 37092

Bruges, , Belgium

Site Status

Teva Investigational Site 37089

Brussels, , Belgium

Site Status

Teva Investigational Site 37091

Hasselt, , Belgium

Site Status

Teva Investigational Site 37090

Liège, , Belgium

Site Status

Teva Investigational Site 54162

Brno, , Czechia

Site Status

Teva Investigational Site 54159

Ostrava, , Czechia

Site Status

Teva Investigational Site 54165

Ostrava-Moravska, , Czechia

Site Status

Teva Investigational Site 54158

Pardubice, , Czechia

Site Status

Teva Investigational Site 54163

Prague, , Czechia

Site Status

Teva Investigational Site 54161

Prague, , Czechia

Site Status

Teva Investigational Site 54164

Prague, , Czechia

Site Status

Teva Investigational Site 54160

Prague, , Czechia

Site Status

Teva Investigational Site 54166

Prague, , Czechia

Site Status

Teva Investigational Site 54157

Rychnov nad Kněžnou, , Czechia

Site Status

Teva Investigational Site 39051

Aalborg, , Denmark

Site Status

Teva Investigational Site 39049

Aarhus, , Denmark

Site Status

Teva Investigational Site 39052

Ballerup Municipality, , Denmark

Site Status

Teva Investigational Site 39048

Glostrup Municipality, , Denmark

Site Status

Teva Investigational Site 39050

Vejle, , Denmark

Site Status

Teva Investigational Site 40034

Helsinki, , Finland

Site Status

Teva Investigational Site 40035

Helsinki, , Finland

Site Status

Teva Investigational Site 40036

Oulu, , Finland

Site Status

Teva Investigational Site 40033

Tampere, , Finland

Site Status

Teva Investigational Site 40032

Turku, , Finland

Site Status

Teva Investigational Site 40037

Turku, , Finland

Site Status

Teva Investigational Site 35237

Bron, , France

Site Status

Teva Investigational Site 35238

Lille, , France

Site Status

Teva Investigational Site 35235

Marseille, , France

Site Status

Teva Investigational Site 35240

Nice, , France

Site Status

Teva Investigational Site 35239

Strasbourg, , France

Site Status

Teva Investigational Site 35236

Voiron, , France

Site Status

Teva Investigational Site 32697

Berlin, , Germany

Site Status

Teva Investigational Site 32690

Berlin, , Germany

Site Status

Teva Investigational Site 32694

Bochum, , Germany

Site Status

Teva Investigational Site 32699

Essen, , Germany

Site Status

Teva Investigational Site 32692

Göppingen, , Germany

Site Status

Teva Investigational Site 32691

Halle, , Germany

Site Status

Teva Investigational Site 32698

Hamburg, , Germany

Site Status

Teva Investigational Site 32700

Kiel, , Germany

Site Status

Teva Investigational Site 32695

Königstein im Taunus, , Germany

Site Status

Teva Investigational Site 32689

München, , Germany

Site Status

Teva Investigational Site 32701

Rostock, , Germany

Site Status

Teva Investigational Site 32693

Ulm, , Germany

Site Status

Teva Investigational Site 30199

Florence, , Italy

Site Status

Teva Investigational Site 30204

Roma, , Italy

Site Status

Teva Investigational Site 38126

Amsterdam, , Netherlands

Site Status

Teva Investigational Site 38127

Blaricum, , Netherlands

Site Status

Teva Investigational Site 38124

Leiden, , Netherlands

Site Status

Teva Investigational Site 38125

Tilburg, , Netherlands

Site Status

Teva Investigational Site 53420

Krakow, , Poland

Site Status

Teva Investigational Site 53425

Krakow, , Poland

Site Status

Teva Investigational Site 53422

Lodz, , Poland

Site Status

Teva Investigational Site 53424

Lodz, , Poland

Site Status

Teva Investigational Site 53418

Lublin, , Poland

Site Status

Teva Investigational Site 53416

Poznan, , Poland

Site Status

Teva Investigational Site 53419

Szczecin, , Poland

Site Status

Teva Investigational Site 53417

Warsaw, , Poland

Site Status

Teva Investigational Site 53423

Warsaw, , Poland

Site Status

Teva Investigational Site 31231

Barcelona, , Spain

Site Status

Teva Investigational Site 31235

Madrid, , Spain

Site Status

Teva Investigational Site 31236

Madrid, , Spain

Site Status

Teva Investigational Site 31226

Pamplona, , Spain

Site Status

Teva Investigational Site 31229

Santander, , Spain

Site Status

Teva Investigational Site 31230

Santiago de Compostela, , Spain

Site Status

Teva Investigational Site 31234

Seville, , Spain

Site Status

Teva Investigational Site 31233

Valencia, , Spain

Site Status

Teva Investigational Site 31227

Valencia, , Spain

Site Status

Teva Investigational Site 31225

Valladolid, , Spain

Site Status

Teva Investigational Site 31228

Zaragoza, , Spain

Site Status

Teva Investigational Site 42050

Helsingborg, , Sweden

Site Status

Teva Investigational Site 42049

Huddinge, , Sweden

Site Status

Teva Investigational Site 42051

Lund, , Sweden

Site Status

Teva Investigational Site 42052

Stockholm, , Sweden

Site Status

Teva Investigational Site 42054

Stockholm, , Sweden

Site Status

Teva Investigational Site 45018

Bad Zurzach, , Switzerland

Site Status

Teva Investigational Site 45016

Bern, , Switzerland

Site Status

Teva Investigational Site 45017

Lugano, , Switzerland

Site Status

Teva Investigational Site 34231

Glasgow, , United Kingdom

Site Status

Teva Investigational Site 34232

Hull, , United Kingdom

Site Status

Teva Investigational Site 34233

London, , United Kingdom

Site Status

Teva Investigational Site 34230

Oxford, , United Kingdom

Site Status

Teva Investigational Site 34235

Salford, , United Kingdom

Site Status

Teva Investigational Site 34236

Stoke-on-Trent, , United Kingdom

Site Status

Countries

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United States Belgium Czechia Denmark Finland France Germany Italy Netherlands Poland Spain Sweden Switzerland United Kingdom

References

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McAllister P, Cohen JM, Campos VR, Ning X, Janka L, Barash S. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. J Headache Pain. 2022 Aug 29;23(1):112. doi: 10.1186/s10194-022-01438-4.

Reference Type DERIVED
PMID: 36038833 (View on PubMed)

Diener HC, McAllister P, Jurgens TP, Kessler Y, Ning X, Cohen JM, Campos VR, Barash S, Silberstein SD. Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. Cephalalgia. 2022 Jul;42(8):769-780. doi: 10.1177/03331024221076485. Epub 2022 Mar 25.

Reference Type DERIVED
PMID: 35331009 (View on PubMed)

Lampl C, Rapoport AM, Cohen JM, Barash S, Ramirez Campos V, Seminerio MJ, Ning X, Silberstein SD. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 Jul;29(7):2129-2137. doi: 10.1111/ene.15328. Epub 2022 Mar 29.

Reference Type DERIVED
PMID: 35302681 (View on PubMed)

MaassenVanDenBrink A, Terwindt GM, Cohen JM, Barash S, Campos VR, Galic M, Ning X, Karppa M. Impact of age and sex on the efficacy of fremanezumab in patients with difficult-to-treat migraine: results of the randomized, placebo-controlled, phase 3b FOCUS study. J Headache Pain. 2021 Dec 18;22(1):152. doi: 10.1186/s10194-021-01336-1.

Reference Type DERIVED
PMID: 34922436 (View on PubMed)

Nahas SJ, Naegel S, Cohen JM, Ning X, Janka L, Campos VR, Krasenbaum LJ, Holle-Lee D, Kudrow D, Lampl C. Efficacy and safety of fremanezumab in clinical trial participants aged >/=60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. J Headache Pain. 2021 Nov 24;22(1):141. doi: 10.1186/s10194-021-01351-2.

Reference Type DERIVED
PMID: 34819017 (View on PubMed)

Ashina M, Cohen JM, Galic M, Campos VR, Barash S, Ning X, Kessler Y, Janka L, Diener HC. Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study. J Headache Pain. 2021 Jul 10;22(1):68. doi: 10.1186/s10194-021-01279-7.

Reference Type DERIVED
PMID: 34246226 (View on PubMed)

Pazdera L, Cohen JM, Ning X, Campos VR, Yang R, Pozo-Rosich P. Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response. Cephalalgia. 2021 Sep;41(10):1075-1088. doi: 10.1177/03331024211008401. Epub 2021 May 14.

Reference Type DERIVED
PMID: 33990144 (View on PubMed)

Spierings ELH, Karppa M, Ning X, Cohen JM, Campos VR, Yang R, Reuter U. Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial. J Headache Pain. 2021 Apr 16;22(1):26. doi: 10.1186/s10194-021-01232-8.

Reference Type DERIVED
PMID: 33863272 (View on PubMed)

Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16.

Reference Type DERIVED
PMID: 31427046 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-002441-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV48125-CNS-30068

Identifier Type: -

Identifier Source: org_study_id