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Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

NCT ID: NCT02638103

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

1890 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-26

Study Completion Date

2018-12-08

Brief Summary

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A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 \[NCT02621931\] and TV48125-CNS-30050 \[NCT02629861\]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.

Detailed Description

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Conditions

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Migraine

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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TEV-48125 225 mg Monthly: New/Placebo Rollover Participants

Participants with CM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 milligrams (mg) SC as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters \[mL\] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

Placebo

Intervention Type DRUG

Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

TEV-48125 225 mg Monthly: Active Rollover Participants

Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

Placebo

Intervention Type DRUG

Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants

Participants with CM or EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

Placebo

Intervention Type DRUG

Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

TEV-48125 675 mg Quarterly: Active Rollover Participants

Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

Placebo

Intervention Type DRUG

Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

Interventions

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Fremanezumab

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

Intervention Type DRUG

Placebo

Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

Intervention Type DRUG

Other Intervention Names

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TEV-48125

Eligibility Criteria

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Inclusion Criteria

Participants Rolling Over from the Pivotal Efficacy Studies:

* Participant must have signed and dated the informed consent document.
* Participant must have completed the pivotal efficacy study without major protocol violations.

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

Participants Not Rolling Over from the Pivotal Efficacy Studies:

* Males or females aged 18 to 70 years, inclusive, with migraine onset at less than or equal to (≤) 50 years of age.
* Participant signed and dated the informed consent document.
* Participant has a history of migraine or clinical judgment suggests a migraine diagnosis.
* Participant fulfills the criteria for EM or CM with prospectively collected baseline information during the 28-day run-in period.
* Body mass index (BMI) of 17.5 to 37.5 kilograms/square meter (kg/m\^2) and a total body weight between 45 and 120 kg, inclusive.
* All participants must be of non-childbearing potential.

1. Participants must simultaneously use 2 forms of highly effective contraception methods.
2. Participants will remain abstinent throughout the study.
* Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test prior at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
* The participant must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation.

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

Exclusion Criteria

Participants Rolling Over from the Pivotal Efficacy Studies:

* Pregnant or nursing females
* Compliance with daily diary entry lower than 75 percent (%) at the last month of the double-blind treatment period of the pivotal efficacy study.

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

Participants Not Rolling Over from the Pivotal Efficacy Studies:

* Clinically significant findings at the discretion of the investigator.
* Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years.
* History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[for example; cerebral ischemia\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events) such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism -Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection.
* Past or current history of cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma.
* Pregnant or nursing females.
* History of hypersensitivity reactions to injected proteins, including monoclonal antibodies.
* Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer.
* History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years.
* The participant cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:

1. mentally or legally incapacitated or unable to give consent for any reason.
2. in custody due to an administrative or a legal decision, under guardianship, or institutionalized.
3. unable to be contacted in case of emergency.
4. has any other condition, which, in the opinion of the investigator, makes the participant inappropriate for inclusion in the study.
* Participant is a study center or sponsor employee who is directly involved in the study or the relative of such an employee.

* 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 13628

Birmingham, Alabama, United States

Site Status

Teva Investigational Site 13577

Birmingham, Alabama, United States

Site Status

Teva Investigational Site 13606

Phoenix, Arizona, United States

Site Status

Teva Investigational Site 13579

Phoenix, Arizona, United States

Site Status

Teva Investigational Site 13602

Little Rock, Arkansas, United States

Site Status

Teva Investigational Site 13568

Encino, California, United States

Site Status

Teva Investigational Site 13546

Fullerton, California, United States

Site Status

Teva Investigational Site 13540

Long Beach, California, United States

Site Status

Teva Investigational Site 13632

Redlands, California, United States

Site Status

Teva Investigational Site 13571

Redondo Beach, California, United States

Site Status

Teva Investigational Site 13573

San Diego, California, United States

Site Status

Teva Investigational Site 13538

Santa Monica, California, United States

Site Status

Teva Investigational Site 13594

Santa Rosa, California, United States

Site Status

Teva Investigational Site 13595

Walnut Creek, California, United States

Site Status

Teva Investigational Site 13629

Aurora, Colorado, United States

Site Status

Teva Investigational Site 13557

Boulder, Colorado, United States

Site Status

Teva Investigational Site 13593

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 13633

Denver, Colorado, United States

Site Status

Teva Investigational Site 13612

Denver, Colorado, United States

Site Status

Teva Investigational Site 13631

Englewood, Colorado, United States

Site Status

Teva Investigational Site 13563

East Hartford, Connecticut, United States

Site Status

Teva Investigational Site 13550

Stamford, Connecticut, United States

Site Status

Teva Investigational Site 13635

Bradenton, Florida, United States

Site Status

Teva Investigational Site 13597

Gainesville, Florida, United States

Site Status

Teva Investigational Site 13607

Hialeah, Florida, United States

Site Status

Teva Investigational Site 13559

Jacksonville, Florida, United States

Site Status

Teva Investigational Site 13584

Ocala, Florida, United States

Site Status

Teva Investigational Site 13587

Orlando, Florida, United States

Site Status

Teva Investigational Site 13567

Palm Beach Gardens, Florida, United States

Site Status

Teva Investigational Site 13553

Pembroke Pines, Florida, United States

Site Status

Teva Investigational Site 13616

Pinellas Park, Florida, United States

Site Status

Teva Investigational Site 13620

Atlanta, Georgia, United States

Site Status

Teva Investigational Site 13537

Atlanta, Georgia, United States

Site Status

Teva Investigational Site 13604

Boise, Idaho, United States

Site Status

Teva Investigational Site 13585

Chicago, Illinois, United States

Site Status

Teva Investigational Site 13621

Chicago, Illinois, United States

Site Status

Teva Investigational Site 13627

Evanston, Illinois, United States

Site Status

Teva Investigational Site 13596

Indianapolis, Indiana, United States

Site Status

Teva Investigational Site 13617

Wichita, Kansas, United States

Site Status

Teva Investigational Site 13598

Wichita, Kansas, United States

Site Status

Teva Investigational Site 13566

Louisville, Kentucky, United States

Site Status

Teva Investigational Site 13603

Metairie, Louisiana, United States

Site Status

Teva Investigational Site 13582

Pikesville, Maryland, United States

Site Status

Teva Investigational Site 13590

Boston, Massachusetts, United States

Site Status

Teva Investigational Site 13589

New Bedford, Massachusetts, United States

Site Status

Teva Investigational Site 13543

Watertown, Massachusetts, United States

Site Status

Teva Investigational Site 13539

Ann Arbor, Michigan, United States

Site Status

Teva Investigational Site 13542

Golden Valley, Minnesota, United States

Site Status

Teva Investigational Site 13534

Kansas City, Missouri, United States

Site Status

Teva Investigational Site 13536

Springfield, Missouri, United States

Site Status

Teva Investigational Site 13619

St Louis, Missouri, United States

Site Status

Teva Investigational Site 13618

Fremont, Nebraska, United States

Site Status

Teva Investigational Site 13605

Las Vegas, Nevada, United States

Site Status

Teva Investigational Site 13578

Lebanon, New Hampshire, United States

Site Status

Teva Investigational Site 13575

Martinsville, New Jersey, United States

Site Status

Teva Investigational Site 13622

Princeton, New Jersey, United States

Site Status

Teva Investigational Site 13588

Albuquerque, New Mexico, United States

Site Status

Teva Investigational Site 13576

Amherst, New York, United States

Site Status

Teva Investigational Site 13565

Plainview, New York, United States

Site Status

Teva Investigational Site 13544

Greensboro, North Carolina, United States

Site Status

Teva Investigational Site 13574

Greensboro, North Carolina, United States

Site Status

Teva Investigational Site 13545

Raleigh, North Carolina, United States

Site Status

Teva Investigational Site 13609

Akron, Ohio, United States

Site Status

Teva Investigational Site 13625

Akron, Ohio, United States

Site Status

Teva Investigational Site 13634

Akron, Ohio, United States

Site Status

Teva Investigational Site 13533

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 13624

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 13569

Cleveland, Ohio, United States

Site Status

Teva Investigational Site 13626

Columbus, Ohio, United States

Site Status

Teva Investigational Site 13561

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 13601

Eugene, Oregon, United States

Site Status

Teva Investigational Site 13591

Jenkintown, Pennsylvania, United States

Site Status

Teva Investigational Site 13554

Philadelphia, Pennsylvania, United States

Site Status

Teva Investigational Site 13608

Uniontown, Pennsylvania, United States

Site Status

Teva Investigational Site 13615

Greer, South Carolina, United States

Site Status

Teva Investigational Site 13556

Mt. Pleasant, South Carolina, United States

Site Status

Teva Investigational Site 13560

Bristol, Tennessee, United States

Site Status

Teva Investigational Site 13551

Memphis, Tennessee, United States

Site Status

Teva Investigational Site 13532

Nashville, Tennessee, United States

Site Status

Teva Investigational Site 13552

Nashville, Tennessee, United States

Site Status

Teva Investigational Site 13541

Austin, Texas, United States

Site Status

Teva Investigational Site 13623

Dallas, Texas, United States

Site Status

Teva Investigational Site 13611

Plano, Texas, United States

Site Status

Teva Investigational Site 13572

San Antonio, Texas, United States

Site Status

Teva Investigational Site 13614

Murray, Utah, United States

Site Status

Teva Investigational Site 13581

West Jordan, Utah, United States

Site Status

Teva Investigational Site 13630

Virginia Beach, Virginia, United States

Site Status

Teva Investigational Site 13564

Seattle, Washington, United States

Site Status

Teva Investigational Site 13586

Seattle, Washington, United States

Site Status

Teva Investigational Site 13600

Morgantown, West Virginia, United States

Site Status

Teva Investigational Site 11124

Hamilton, Ontario, Canada

Site Status

Teva Investigational Site 11122

Newmarket, Ontario, Canada

Site Status

Teva Investigational Site 11120

Calgary, , Canada

Site Status

Teva Investigational Site 11121

Montreal, , Canada

Site Status

Teva Investigational Site 11123

Sarnia, , Canada

Site Status

Teva Investigational Site 54144

Brno, , Czechia

Site Status

Teva Investigational Site 54141

Kunratice, , Czechia

Site Status

Teva Investigational Site 54145

Pardubice, , Czechia

Site Status

Teva Investigational Site 54143

Prague, , Czechia

Site Status

Teva Investigational Site 54146

Prague, , Czechia

Site Status

Teva Investigational Site 54142

Prague, , Czechia

Site Status

Teva Investigational Site 40018

Helsinki, , Finland

Site Status

Teva Investigational Site 40017

Helsinki, , Finland

Site Status

Teva Investigational Site 40016

Turku, , Finland

Site Status

Teva Investigational Site 80096

Holon, , Israel

Site Status

Teva Investigational Site 80099

Jerusalem, , Israel

Site Status

Teva Investigational Site 80098

Nahariya, , Israel

Site Status

Teva Investigational Site 80097

Netanya, , Israel

Site Status

Teva Investigational Site 80100

Ramat Gan, , Israel

Site Status

Teva Investigational Site 80095

Tel Aviv, , Israel

Site Status

Teva Investigational Site 84072

Chofu-shi, , Japan

Site Status

Teva Investigational Site 84066

Kagoshima, , Japan

Site Status

Teva Investigational Site 84069

Kai, , Japan

Site Status

Teva Investigational Site 84073

Kawasaki, , Japan

Site Status

Teva Investigational Site 84067

Kyoto, , Japan

Site Status

Teva Investigational Site 84062

Osaka, , Japan

Site Status

Teva Investigational Site 84070

Saitama, , Japan

Site Status

Teva Investigational Site 84061

Sendai, , Japan

Site Status

Teva Investigational Site 84063

Shinjuku-ku, , Japan

Site Status

Teva Investigational Site 84068

Shizuoka, , Japan

Site Status

Teva Investigational Site 84065

Tochigi, , Japan

Site Status

Teva Investigational Site 84064

Tokyo, , Japan

Site Status

Teva Investigational Site 84071

Toyonaka, , Japan

Site Status

Teva Investigational Site 53364

Krakow, , Poland

Site Status

Teva Investigational Site 53363

Krakow, , Poland

Site Status

Teva Investigational Site 53366

Lublin, , Poland

Site Status

Teva Investigational Site 53365

Poznan, , Poland

Site Status

Teva Investigational Site 53367

Warsaw, , Poland

Site Status

Teva Investigational Site 50399

Kazan', , Russia

Site Status

Teva Investigational Site 50395

Kazan', , Russia

Site Status

Teva Investigational Site 50394

Moscow, , Russia

Site Status

Teva Investigational Site 50400

Moscow, , Russia

Site Status

Teva Investigational Site 50398

Nizhny Novgorod, , Russia

Site Status

Teva Investigational Site 50396

Nizhny Novgorod, , Russia

Site Status

Teva Investigational Site 50397

Ufa, , Russia

Site Status

Teva Investigational Site 31207

Madrid, , Spain

Site Status

Teva Investigational Site 31208

Pamplona, , Spain

Site Status

Teva Investigational Site 31205

Valladolid, , Spain

Site Status

Teva Investigational Site 31206

Zaragoza, , Spain

Site Status

Countries

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Denmark Germany Hungary Italy Ukraine United States Canada Czechia Finland Israel Japan Poland Russia Spain

References

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Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R, Dodick DW. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020 Nov 3;95(18):e2487-e2499. doi: 10.1212/WNL.0000000000010600. Epub 2020 Sep 10.

Reference Type DERIVED
PMID: 32913018 (View on PubMed)

Buse DC, Gandhi SK, Cohen JM, Ramirez-Campos V, Cloud B, Yang R, Cowan RP. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain. 2020 Sep 4;21(1):109. doi: 10.1186/s10194-020-01177-4.

Reference Type DERIVED
PMID: 32887548 (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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2015-004550-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV48125-CNS-30051

Identifier Type: -

Identifier Source: org_study_id