AzTrials
AzTrials

MigrainePhase 3NCT02621931

Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

A Phase 3 study testing Fremanezumab in people with Migraine, run by Teva Branded Pharmaceutical Products R&D, Inc. at 273 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Migraine
What is being tested?
Fremanezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,130 participants
Where
273 sitesin 9 countries
Study dates
22 Mar 2016to 11 Apr 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age
  • Patient signs and dates the informed consent document
  • Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis
  • 85% e-diary compliance
  • Total body weight between 99 and 250 lbs, inclusive
  • Additional criteria apply, please contact the investigator for more information

Who cannot join

  • Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, 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 [eg, 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 last 5 years, except for appropriately treated nonmelanoma skin carcinoma
  • Pregnant or nursing females
Show all 9Show fewer
  • 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 prior to study drug administration or 5 half-lives, whichever is longer
  • Additional criteria apply, please contact the investigator for more information

Trial locations and contacts

273 sites in 9 countries.

273 sites in 9 countries

United States179 sites

  • Teva Investigational Site 13609

    Akron, Ohio, 44311

  • Teva Investigational Site 13634

    Akron, Ohio, 44311

  • Teva Investigational Site 13609

    Akron, Ohio

  • Teva Investigational Site 13634

    Akron, Ohio

  • Teva Investigational Site 13588

    Albuquerque, New Mexico, 87102

  • Teva Investigational Site 13588

    Albuquerque, New Mexico

  • Teva Investigational Site 13576

    Amherst, New York, 14226

  • Teva Investigational Site 13576

    Amherst, New York

  • Teva Investigational Site 13539

    Ann Arbor, Michigan, 48104

  • Teva Investigational Site 13539

    Ann Arbor, Michigan

  • Teva Investigational Site 13620

    Atlanta, Georgia, 30312

  • Teva Investigational Site 13537

    Atlanta, Georgia, 30342

  • Teva Investigational Site 13537

    Atlanta, Georgia

  • Teva Investigational Site 13620

    Atlanta, Georgia

  • Teva Investigational Site 13629

    Aurora, Colorado, 80014

  • Teva Investigational Site 13629

    Aurora, Colorado

  • Teva Investigational Site 13541

    Austin, Texas, 78731

  • Teva Investigational Site 13541

    Austin, Texas

  • Teva Investigational Site 13582

    Baltimore, Maryland

  • Teva Investigational Site 13628

    Birmingham, Alabama, 35211

  • Teva Investigational Site 13577

    Birmingham, Alabama, 35216

  • Teva Investigational Site 13577

    Birmingham, Alabama

  • Teva Investigational Site 13628

    Birmingham, Alabama

  • Teva Investigational Site 13604

    Boise, Idaho

  • Teva Investigational Site 13590

    Boston, Massachusetts, 02131

  • Teva Investigational Site 13590

    Boston, Massachusetts

  • Teva Investigational Site 13557

    Boulder, Colorado, 80301

  • Teva Investigational Site 13557

    Boulder, Colorado

  • Teva Investigational Site 13635

    Bradenton, Florida, 34201

  • Teva Investigational Site 13635

    Bradenton, Florida

  • Teva Investigational Site 13560

    Bristol, Tennessee, 37620

  • Teva Investigational Site 13560

    Bristol, Tennessee

  • Teva Investigational Site 13585

    Chicago, Illinois, 60607

  • Teva Investigational Site 13621

    Chicago, Illinois, 60654

  • Teva Investigational Site 13585

    Chicago, Illinois

  • Teva Investigational Site 13621

    Chicago, Illinois

  • Teva Investigational Site 13533

    Cincinnati, Ohio, 45227

  • Teva Investigational Site 13624

    Cincinnati, Ohio, 45249

  • Teva Investigational Site 13533

    Cincinnati, Ohio

  • Teva Investigational Site 13624

    Cincinnati, Ohio

  • Teva Investigational Site 13569

    Cleveland, Ohio, 44195

  • Teva Investigational Site 13569

    Cleveland, Ohio

  • Teva Investigational Site 13593

    Colorado Springs, Colorado, 80918

  • Teva Investigational Site 13593

    Colorado Springs, Colorado

  • Teva Investigational Site 13626

    Columbus, Ohio, 43212

  • Teva Investigational Site 13626

    Columbus, Ohio

  • Teva Investigational Site 13623

    Dallas, Texas, 75214

  • Teva Investigational Site 13623

    Dallas, Texas

  • Teva Investigational Site 13633

    Denver, Colorado, 80210

  • Teva Investigational Site 13612

    Denver, Colorado, 80239

  • Teva Investigational Site 13612

    Denver, Colorado

  • Teva Investigational Site 13633

    Denver, Colorado

  • Teva Investigational Site 13563

    East Hartford, Connecticut, 06118

  • Teva Investigational Site 13563

    East Hartford, Connecticut

  • Teva Investigational Site 13568

    Encino, California, 91316

  • Teva Investigational Site 13568

    Encino, California

  • Teva Investigational Site 13631

    Englewood, Colorado, 80113

  • Teva Investigational Site 13631

    Englewood, Colorado

  • Teva Investigational Site 13601

    Eugene, Oregon, 97401

  • Teva Investigational Site 13601

    Eugene, Oregon

  • Teva Investigational Site 13627

    Evanston, Illinois, 60201

  • Teva Investigational Site 13627

    Evanston, Illinois

  • Teva Investigational Site 13618

    Fremont, Nebraska, 68025

  • Teva Investigational Site 13618

    Fremont, Nebraska

  • Teva Investigational Site 13546

    Fullerton, California, 92835

  • Teva Investigational Site 13546

    Fullerton, California

  • Teva Investigational Site 13597

    Gainesville, Florida, 32607

  • Teva Investigational Site 13597

    Gainesville, Florida

  • Teva Investigational Site 13542

    Golden Valley, Minnesota, 55422

  • Teva Investigational Site 13542

    Golden Valley, Minnesota

  • Teva Investigational Site 13544

    Greensboro, North Carolina, 27401

  • Teva Investigational Site 13574

    Greensboro, North Carolina, 27408

  • Teva Investigational Site 13544

    Greensboro, North Carolina

  • Teva Investigational Site 13574

    Greensboro, North Carolina

  • Teva Investigational Site 13615

    Greer, South Carolina, 29650

  • Teva Investigational Site 13615

    Greer, South Carolina

  • Teva Investigational Site 13607

    Hialeah, Florida, 33012

  • Teva Investigational Site 13607

    Hialeah, Florida

  • Teva Investigational Site 13596

    Indianapolis, Indiana, 46254

  • Teva Investigational Site 13596

    Indianapolis, Indiana

  • Teva Investigational Site 13559

    Jacksonville, Florida, 32205

  • Teva Investigational Site 13559

    Jacksonville, Florida

  • Teva Investigational Site 13591

    Jenkintown, Pennsylvania, 19046

  • Teva Investigational Site 13591

    Jenkintown, Pennsylvania

  • Teva Investigational Site 13534

    Kansas City, Missouri, 64114

  • Teva Investigational Site 13534

    Kansas City, Missouri

  • Teva Investigational Site 13605

    Las Vegas, Nevada, 89106

  • Teva Investigational Site 13605

    Las Vegas, Nevada

  • Teva Investigational Site 13578

    Lebanon, New Hampshire, 03756

  • Teva Investigational Site 13578

    Lebanon, New Hampshire

  • Teva Investigational Site 13602

    Little Rock, Arkansas, 72205

  • Teva Investigational Site 13602

    Little Rock, Arkansas

  • Teva Investigational Site 13540

    Long Beach, California, 90806

  • Teva Investigational Site 13540

    Long Beach, California

  • Teva Investigational Site 13566

    Louisville, Kentucky, 40207

  • Teva Investigational Site 13566

    Louisville, Kentucky

  • Teva Investigational Site 13575

    Martinsville, New Jersey

  • Teva Investigational Site 13604

    Meridian, Idaho, 83642

  • Teva Investigational Site 13603

    Metairie, Louisiana, 70006

  • Teva Investigational Site 13603

    Metairie, Louisiana

  • Teva Investigational Site 13625

    Mogadore, Ohio, 44260

  • Teva Investigational Site 13625

    Mogadore, Ohio

  • Teva Investigational Site 13600

    Morgantown, West Virginia, 26506

  • Teva Investigational Site 13600

    Morgantown, West Virginia

  • Teva Investigational Site 13556

    Mt. Pleasant, South Carolina, 29464

  • Teva Investigational Site 13556

    Mt. Pleasant, South Carolina

  • Teva Investigational Site 13614

    Murray, Utah, 84107

  • Teva Investigational Site 13614

    Murray, Utah

  • Teva Investigational Site 13532

    Nashville, Tennessee, 37203

  • Teva Investigational Site 13552

    Nashville, Tennessee, 37203

  • Teva Investigational Site 13532

    Nashville, Tennessee

  • Teva Investigational Site 13552

    Nashville, Tennessee

  • Teva Investigational Site 13589

    New Bedford, Massachusetts, 02301

  • Teva Investigational Site 13589

    New Bedford, Massachusetts

  • Teva Investigational Site 13584

    Ocala, Florida, 34471

  • Teva Investigational Site 13584

    Ocala, Florida

  • Teva Investigational Site 13561

    Oklahoma City, Oklahoma, 73112

  • Teva Investigational Site 13561

    Oklahoma City, Oklahoma

  • Teva Investigational Site 13587

    Orlando, Florida, 32806

  • Teva Investigational Site 13599

    Orlando, Florida, 32819

  • Teva Investigational Site 13551

    Orlando, Florida

  • Teva Investigational Site 13555

    Orlando, Florida

  • Teva Investigational Site 13587

    Orlando, Florida

  • Teva Investigational Site 13599

    Orlando, Florida

  • Teva Investigational Site 13567

    Palm Beach Gardens, Florida, 33410

  • Teva Investigational Site 13567

    Palm Beach Gardens, Florida

  • Teva Investigational Site 13553

    Pembroke Pines, Florida, 33026

  • Teva Investigational Site 13553

    Pembroke Pines, Florida

  • Teva Investigational Site 13554

    Philadelphia, Pennsylvania, 19107

  • Teva Investigational Site 13554

    Philadelphia, Pennsylvania

  • Teva Investigational Site 13606

    Phoenix, Arizona, 85018

  • Teva Investigational Site 13579

    Phoenix, Arizona, 85023

  • Teva Investigational Site 13579

    Phoenix, Arizona

  • Teva Investigational Site 13606

    Phoenix, Arizona

  • Teva Investigational Site 13582

    Pikesville, Maryland, 21208

  • Teva Investigational Site 13616

    Pinellas Park, Florida, 33781

  • Teva Investigational Site 13616

    Pinellas Park, Florida

  • Teva Investigational Site 13565

    Plainview, New York, 11803

  • Teva Investigational Site 13565

    Plainview, New York

  • Teva Investigational Site 13611

    Plano, Texas, 75024

  • Teva Investigational Site 13611

    Plano, Texas

  • Teva Investigational Site 13545

    Raleigh, North Carolina, 27607

  • Teva Investigational Site 13545

    Raleigh, North Carolina

  • Teva Investigational Site 13575

    Raritan, New Jersey, 08869

  • Teva Investigational Site 13632

    Redlands, California, 92374

  • Teva Investigational Site 13632

    Redlands, California

  • Teva Investigational Site 13571

    Redondo Beach, California, 90277

  • Teva Investigational Site 13571

    Redondo Beach, California

  • Teva Investigational Site 13572

    San Antonio, Texas, 78229

  • Teva Investigational Site 13572

    San Antonio, Texas

  • Teva Investigational Site 13573

    San Diego, California, 92103

  • Teva Investigational Site 13573

    San Diego, California

  • Teva Investigational Site 13538

    Santa Monica, California, 90404

  • Teva Investigational Site 13538

    Santa Monica, California

  • Teva Investigational Site 13594

    Santa Rosa, California, 95405

  • Teva Investigational Site 13594

    Santa Rosa, California

  • Teva Investigational Site 13564

    Seattle, Washington, 98105

  • Teva Investigational Site 13586

    Seattle, Washington, 98105

  • Teva Investigational Site 13564

    Seattle, Washington

  • Teva Investigational Site 13586

    Seattle, Washington

  • Teva Investigational Site 13536

    Springfield, Missouri

  • Teva Investigational Site 13619

    St Louis, Missouri, 63141

  • Teva Investigational Site 13619

    St Louis, Missouri

  • Teva Investigational Site 13550

    Stamford, Connecticut, 06905

  • Teva Investigational Site 13550

    Stamford, Connecticut

  • Teva Investigational Site 13608

    Uniontown, Pennsylvania, 15401

  • Teva Investigational Site 13608

    Uniontown, Pennsylvania

  • Teva Investigational Site 13630

    Virginia Beach, Virginia, 23454

  • Teva Investigational Site 13630

    Virginia Beach, Virginia

  • Teva Investigational Site 13595

    Walnut Creek, California, 94598

  • Teva Investigational Site 13595

    Walnut Creek, California

  • Teva Investigational Site 13543

    Watertown, Massachusetts, 02472

  • Teva Investigational Site 13543

    Watertown, Massachusetts

  • Teva Investigational Site 13581

    West Jordan, Utah, 84088

  • Teva Investigational Site 13581

    West Jordan, Utah

  • Teva Investigational Site 13617

    Wichita, Kansas, 67207

  • Teva Investigational Site 13598

    Wichita, Kansas, 67211

  • Teva Investigational Site 13598

    Wichita, Kansas

  • Teva Investigational Site 13617

    Wichita, Kansas

Other trials in United States

Japan24 sites

  • Teva Investigational Site 84072

    Chofu-shi, 182-0006

  • Teva Investigational Site 84064

    Chofu-shi

  • Teva Investigational Site 84072

    Chofu-shi

  • Teva Investigational Site 84066

    Kagoshima, 892-0844

  • Teva Investigational Site 84066

    Kagoshima

  • Teva Investigational Site 84069

    Kai, 400-0124

  • Teva Investigational Site 84069

    Kaisho

  • Teva Investigational Site 84073

    Kawasaki, 211-8588

  • Teva Investigational Site 84073

    Kawasaki-shi

  • Teva Investigational Site 84067

    Kyoto, 600-8811

  • Teva Investigational Site 84067

    Kyoto

  • Teva Investigational Site 84062

    Osaka, 556-0015

  • Teva Investigational Site 84062

    Osaka

  • Teva Investigational Site 84070

    Saitama, 338-8577

  • Teva Investigational Site 84070

    Saitama-shi

  • Teva Investigational Site 84061

    Sendai, 982-0014

  • Teva Investigational Site 84061

    Sendai

  • Teva Investigational Site 84065

    Shimotsuma

  • Teva Investigational Site 84068

    Shizuoka, 4200-853

  • Teva Investigational Site 84068

    Shizuoka

  • Teva Investigational Site 84065

    Tochigi, 321-0293

  • Teva Investigational Site 84064

    Tokyo, 182-0006

  • Teva Investigational Site 84071

    Toyonaka

  • Teva Investigational Site 84071

    Toyonaka-shi

Other trials in Japan

Russia14 sites

  • Teva Investigational Site 50399

    Kazan', 420012

  • Teva Investigational Site 50395

    Kazan', 420021

  • Teva Investigational Site 50395

    Kazan'

  • Teva Investigational Site 50399

    Kazan'

  • Teva Investigational Site 50394

    Moscow, 121467

  • Teva Investigational Site 50400

    Moscow, 129128

  • Teva Investigational Site 50394

    Moscow

  • Teva Investigational Site 50400

    Moscow

  • Teva Investigational Site 50398

    Nizhny Novgorod, 603126

  • Teva Investigational Site 50396

    Nizhny Novgorod, 603137

  • Teva Investigational Site 50396

    Nizhny Novgorod

  • Teva Investigational Site 50398

    Nizhny Novgorod

  • Teva Investigational Site 50397

    Ufa, 450007

  • Teva Investigational Site 50397

    Ufa

Other trials in Russia

Czechia12 sites

  • Teva Investigational Site 54144

    Brno, 602 00

  • Teva Investigational Site 54144

    Brno

  • Teva Investigational Site 54141

    Kunratice, 14800

  • Teva Investigational Site 54141

    Kunratice

  • Teva Investigational Site 54145

    Pardubice, 53002

  • Teva Investigational Site 54145

    Pardubice

  • Teva Investigational Site 54143

    Prague, 100 00

  • Teva Investigational Site 54146

    Prague, 130 00

  • Teva Investigational Site 54142

    Prague, 140 59

  • Teva Investigational Site 54142

    Prague

  • Teva Investigational Site 54143

    Prague

  • Teva Investigational Site 54146

    Prague

Other trials in Czechia

Canada10 sites

  • Teva Investigational Site 11120

    Calgary, T3M 1M4

  • Teva Investigational Site 11120

    Calgary

  • Teva Investigational Site 11124

    Hamilton, Ontario, L8N 1Y2

  • Teva Investigational Site 11124

    Hamilton, Ontario

  • Teva Investigational Site 11121

    Montreal, H2W 1V1

  • Teva Investigational Site 11121

    Montreal

  • Teva Investigational Site 11122

    Newmarket, L3Y5G8

  • Teva Investigational Site 11122

    Newmarket

  • Teva Investigational Site 11123

    Sarnia, N7T 4X3

  • Teva Investigational Site 11123

    Sarnia

Other trials in Canada

Israel10 sites

  • Teva Investigational Site 80096

    Holon, 58100

  • Teva Investigational Site 80096

    Holon

  • Teva Investigational Site 80099

    Jerusalem, 9112001

  • Teva Investigational Site 80099

    Jerusalem

  • Teva Investigational Site 80098

    Nahariya, 221001

  • Teva Investigational Site 80097

    Netanya, 4244916

  • Teva Investigational Site 80097

    Netanya

  • Teva Investigational Site 80100

    Ramat Gan, 5262160

  • Teva Investigational Site 80100

    Ramat Gan

  • Teva Investigational Site 80095

    Tel Aviv, 64239

Other trials in Israel

Poland10 sites

  • Teva Investigational Site 53364

    Krakow, 31-523

  • Teva Investigational Site 53363

    Krakow, 33-332

  • Teva Investigational Site 53363

    Krakow

  • Teva Investigational Site 53364

    Krakow

  • Teva Investigational Site 53366

    Lublin, 20-022

  • Teva Investigational Site 53366

    Lublin

  • Teva Investigational Site 53365

    Poznan, 60-529

  • Teva Investigational Site 53365

    Poznan

  • Teva Investigational Site 53367

    Warsaw, 04-730

  • Teva Investigational Site 53367

    Warsaw

Other trials in Poland

Spain8 sites

  • Teva Investigational Site 31207

    Madrid, 28046

  • Teva Investigational Site 31207

    Madrid

  • Teva Investigational Site 31208

    Pamplona, 31008

  • Teva Investigational Site 31208

    Pamplona

  • Teva Investigational Site 31205

    Valladolid, 47003

  • Teva Investigational Site 31205

    Valladolid

  • Teva Investigational Site 31206

    Zaragoza, 50009

  • Teva Investigational Site 31206

    Zaragoza

Other trials in Spain

Finland6 sites

  • Teva Investigational Site 40018

    Helsinki, 00100

  • Teva Investigational Site 40017

    Helsinki, 00930

  • Teva Investigational Site 40017

    Helsinki

  • Teva Investigational Site 40018

    Helsinki

  • Teva Investigational Site 40016

    Turku, 20100

  • Teva Investigational Site 40016

    Turku

Other trials in Finland

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

Conditions
Migraine
Being tested
Fremanezumab, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FremanezumabDrug

    Also called TEV-48125, anti-calcitonin gene-related peptide (anti-CGRP)

    Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.

  • PlaceboDrug

    Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.

Study groups in NCT02621931
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Placebo
Fremanezumab 675 mg/placebo/placeboExperimentalParticipants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
Receives: Drug: Fremanezumab; Drug: Placebo
Fremanezumab 675/225/225 mgExperimentalParticipants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.
Receives: Drug: Fremanezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug

    Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.

    Measured: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)

  2. Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: Day 1 to Week 12

Secondary outcomes (13)

  1. Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug

    A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.

    Measured: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)

  2. Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity

    Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered non-responders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The percentage reduction in monthly average is calculated as: ((baseline value - post-baseline value) / baseline value) * 100.

    Measured: Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)

  3. Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug

    Participants recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.

    Measured: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)

  4. Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the 4 Week Period After the First Dose of Study Drug

    Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. The change is calculated as post-baseline value - baseline value.

    Measured: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)

  5. Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications

    A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of >= moderate severity was defined as a calendar day where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of >= moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. Change is post-baseline value - baseline value.

    Measured: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)

  6. Change From Baseline in Migraine-Related Disability Score, As Measured by the 6-Item Headache Impact Test (HIT) At Week 12

    The HIT-6 was developed by Kosinski et al (2003) as a short form for reliably assessing the adverse headache impact in clinical practice and clinical research settings. The questionnaire measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It also assesses headache severity. Scores range from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the patient, i.e. scores ≤49 represent little or no impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact; and scores ≥60 indicate severe impact. Negative change from baseline values indicate less adverse impact of headache.

    Measured: Baseline, 12 weeks

  7. Electrocardiogram (ECG) Findings Shifts From Baseline to Overall

    12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the participant is summarized. Only participants with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant. - CS= abnormal, clinically significant. Shift format is: baseline finding / worst post-baseline finding.

    Measured: Baseline (Day 0), Treatment Week 12 (or endpoint)

  8. Participants With Vital Signs Potentially Clinically Significant Abnormal Values

    Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with potentially clinically significant abnormal findings included: - Pulse Rate High: >=120 and increase of >=15 beats per minute - Pulse Rate Low: <=50 and decrease of >=15 beats per minute - Systolic Blood Pressure Low: <=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure High: >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure Low: <=50 mmHg and decrease of >=15 mmHg - Respiratory Rate Low: <10 breaths / minute

    Measured: Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading may reflect the baseline reading performed on Day 0.

  9. Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results

    Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: >=10.71 mmol/L - Creatinine High: >=177 umol/L - Bilirubin High: >=34.2 umol/L - Alanine Aminotransferase (ALT): >=3*upper limit of normal (ULN) - Aspartate Aminotransferase (AST): >=3*upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): >=3*upper limit of normal (ULN) - Hemoglobin: Male: <115 g/L or Female: <=95 g/L - Hematocrit: Male: <0.37 L/L or Female: <0.32 L/L - Leukocytes: >=20*10^9/L or <=3*10^9/L - Eosinophils/Leukocytes: >=10% - Platelets: >=700*10^9/L or <=75*10^9/L

    Measured: Treatment Days 28, 56 and 84 (or endpoint)

  10. Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results

    Urinalysis with potentially clinically significant abnormal findings included: - Blood: >=2 unit increase from baseline - Urine Glucose (mg/dL): >=2 unit increase from baseline - Ketones (mg/dL): >=2 unit increase from baseline - Urine Protein (mg/dL): >=2 unit increase from baseline

    Measured: Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading reflect the baseline reading performed on Day 0.

  11. Prothrombin Time Shifts From Baseline to Endpoint

    Shifts in prothrombin time from baseline to endpoint were summarized using patient counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range) Shift format is: baseline finding / endpoint finding

    Measured: Baseline (Day 0), Treatment Endpoint (Week 12)

  12. Injection Site Reaction Adverse Events

    Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.

    Measured: Day 1 to Week 12

  13. Participants With Positive Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) Results After the First Dose of Study Drug

    The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the participant's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

    The eC-SSRS Baseline/Screening version was completed by the participant at baseline, and the eC-SSRS Since Last Visit version was completed by the participant at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized.

    Measured: Baseline (Day 0), Treatment Days 28, 56, 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2015 (estimated)
  2. Study start22 Mar 2016
  3. Primary completion11 Apr 2017
  4. Study completion11 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02621931
Sponsor's protocol ID
TV48125-CNS-30049
Other IDs
2015-004549-23, 2015
Status last verified
Nov 2021
First submitted
2 Dec 2015
Last updated
9 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36038833

  • 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.

    PubMed 35331009

  • 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.

    PubMed 34819017

  • Silberstein SD, Cohen JM, Yang R, Gandhi SK, Du E, Jann AE, Marmura MJ. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. J Headache Pain. 2021 Jan 7;22(1):2. doi: 10.1186/s10194-020-01212-4.

    PubMed 33413075

  • Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020 Sep 21;21(1):114. doi: 10.1186/s10194-020-01173-8.

    PubMed 32958075

  • Lipton RB, Cohen JM, Gandhi SK, Yang R, Yeung PP, Buse DC. Effect of fremanezumab on quality of life and productivity in patients with chronic migraine. Neurology. 2020 Aug 18;95(7):e878-e888. doi: 10.1212/WNL.0000000000010000. Epub 2020 Aug 3.

    PubMed 32747522

  • Winner PK, Spierings ELH, Yeung PP, Aycardi E, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y. Early Onset of Efficacy With Fremanezumab for the Preventive Treatment of Chronic Migraine. Headache. 2019 Nov;59(10):1743-1752. doi: 10.1111/head.13654. Epub 2019 Nov 1.

    PubMed 31675102

  • Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017 Nov 30;377(22):2113-2122. doi: 10.1056/NEJMoa1709038.

    PubMed 29171818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fremanezumab in people with Migraine, run by Teva Branded Pharmaceutical Products R&D, Inc. at 273 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 273 sites in United States, Japan, Russia, Czechia, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug (time frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02621931, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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