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NCT02621931

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

NCT ID: NCT02621931

Last Updated: 2021-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-22

Study Completion Date

2017-04-11

Brief Summary

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

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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Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Fremanezumab 675 mg/placebo/placebo

Participants 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.

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

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

Fremanezumab 675/225/225 mg

Participants 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.

Group Type EXPERIMENTAL

Fremanezumab

Intervention Type DRUG

Interventions

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Fremanezumab

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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 54145

Pardubice, , Czechia

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Teva Investigational Site 54143

Prague, , Czechia

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Teva Investigational Site 54146

Prague, , Czechia

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Teva Investigational Site 54142

Prague, , Czechia

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Teva Investigational Site 54142

Prague, , Czechia

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Teva Investigational Site 54143

Prague, , Czechia

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Teva Investigational Site 11122

Newmarket, , Canada

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Teva Investigational Site 11123

Sarnia, , Canada

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Teva Investigational Site 11123

Sarnia, , Canada

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Teva Investigational Site 54144

Brno, , Czechia

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Teva Investigational Site 54144

Brno, , Czechia

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Teva Investigational Site 54141

Kunratice, , Czechia

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Teva Investigational Site 54141

Kunratice, , Czechia

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Teva Investigational Site 13628

Birmingham, Alabama, United States

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Teva Investigational Site 13577

Birmingham, Alabama, United States

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Teva Investigational Site 13577

Birmingham, Alabama, United States

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Teva Investigational Site 13628

Birmingham, Alabama, United States

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Teva Investigational Site 13606

Phoenix, Arizona, United States

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Teva Investigational Site 13579

Phoenix, Arizona, United States

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Teva Investigational Site 13579

Phoenix, Arizona, United States

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Teva Investigational Site 13606

Phoenix, Arizona, United States

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Teva Investigational Site 13602

Little Rock, Arkansas, United States

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Teva Investigational Site 13602

Little Rock, Arkansas, United States

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Teva Investigational Site 13568

Encino, California, United States

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Teva Investigational Site 13568

Encino, California, United States

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Teva Investigational Site 13546

Fullerton, California, United States

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Teva Investigational Site 13546

Fullerton, California, United States

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Teva Investigational Site 13540

Long Beach, California, United States

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Teva Investigational Site 13540

Long Beach, California, United States

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Teva Investigational Site 13632

Redlands, California, United States

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Teva Investigational Site 13632

Redlands, California, United States

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Teva Investigational Site 13571

Redondo Beach, California, United States

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Teva Investigational Site 13571

Redondo Beach, California, United States

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Teva Investigational Site 13573

San Diego, California, United States

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Teva Investigational Site 13573

San Diego, California, United States

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Teva Investigational Site 13538

Santa Monica, California, United States

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Teva Investigational Site 13538

Santa Monica, California, United States

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Teva Investigational Site 13594

Santa Rosa, California, United States

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Teva Investigational Site 13594

Santa Rosa, California, United States

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Teva Investigational Site 13595

Walnut Creek, California, United States

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Teva Investigational Site 13595

Walnut Creek, California, United States

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Teva Investigational Site 13629

Aurora, Colorado, United States

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Teva Investigational Site 13629

Aurora, Colorado, United States

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Teva Investigational Site 13557

Boulder, Colorado, United States

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Teva Investigational Site 13557

Boulder, Colorado, United States

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Teva Investigational Site 13593

Colorado Springs, Colorado, United States

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Teva Investigational Site 13593

Colorado Springs, Colorado, United States

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Teva Investigational Site 13633

Denver, Colorado, United States

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Teva Investigational Site 13612

Denver, Colorado, United States

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Teva Investigational Site 13612

Denver, Colorado, United States

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Teva Investigational Site 13633

Denver, Colorado, United States

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Teva Investigational Site 13631

Englewood, Colorado, United States

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Teva Investigational Site 13631

Englewood, Colorado, United States

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Teva Investigational Site 13563

East Hartford, Connecticut, United States

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Teva Investigational Site 13563

East Hartford, Connecticut, United States

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Teva Investigational Site 13550

Stamford, Connecticut, United States

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Teva Investigational Site 13550

Stamford, Connecticut, United States

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Teva Investigational Site 13635

Bradenton, Florida, United States

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Teva Investigational Site 13635

Bradenton, Florida, United States

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Teva Investigational Site 13597

Gainesville, Florida, United States

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Teva Investigational Site 13597

Gainesville, Florida, United States

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Teva Investigational Site 13607

Hialeah, Florida, United States

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Teva Investigational Site 13607

Hialeah, Florida, United States

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Teva Investigational Site 13559

Jacksonville, Florida, United States

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Teva Investigational Site 13559

Jacksonville, Florida, United States

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Teva Investigational Site 13584

Ocala, Florida, United States

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