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

• ClinicalTrials.gov Identifier: NCT02638103
• Recruitment Status: Completed
• First Posted: December 22, 2015
• Results First Posted: August 28, 2019
• Last Update Posted: February 28, 2020
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by (Responsible Party): Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Migraine	Drug: Fremanezumab; Drug: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1890 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine
• Actual Study Start Date: February 26, 2016
• Actual Primary Completion Date: June 6, 2018
• Actual Study Completion Date: December 8, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Drug: Fremanezumab; Fremanezumab will be administered as per the dose and schedule specified in the respective arms.; Other Name: TEV-48125; Drug: Placebo; Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.
Experimental: 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).	Drug: Fremanezumab; Fremanezumab will be administered as per the dose and schedule specified in the respective arms.; Other Name: TEV-48125; Drug: Placebo; Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.
Experimental: 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).	Drug: Fremanezumab; Fremanezumab will be administered as per the dose and schedule specified in the respective arms.; Other Name: TEV-48125; Drug: Placebo; Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.
Experimental: 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).	Drug: Fremanezumab; Fremanezumab will be administered as per the dose and schedule specified in the respective arms.; Other Name: TEV-48125; Drug: Placebo; Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to follow-up visit (Day 533) ]
   An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
2. Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results [ Time Frame: Baseline (Day 0) up to end of treatment (EOT) visit (Day 336) ]
   Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (>=) 10.71 millimoles/liter (mmol/L), creatinine: >=177 micromoles/liter (µmol/L), bilirubin: >=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter [U/L]): >=3*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): >=3*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): >=3*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
3. Number of Participants With Potentially Clinically Significant Abnormal Hematology Results [ Time Frame: Baseline (Day 0) up to EOT visit (Day 336) ]
   Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (<) 115 grams/liter (g/L) (in males) or less than or equal to (<=) 95 g/L (in females), hematocrit: <0.37 L/L (in male) or <0.32 L/L (in female), leukocytes: >=20*10^9/L or <=3*10^9/L, eosinophils/leukocytes: >=10%, and platelets: >=700*10^9/L or <=75*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
4. Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results [ Time Frame: Baseline (Day 0) up to EOT visit (Day 336) ]
   Potentially clinically significant abnormal urinalysis findings included: blood: >=2 unit increase from baseline, urine glucose (milligrams/decilitre [mg/dL]): >=2 unit increase from baseline, ketones (mg/dL): >=2 unit increase from baseline, urine protein (mg/dL): >=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
5. Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values [ Time Frame: Baseline (Day 0) up to EOT visit (Day 336) ]
   Potentially clinically significant abnormal vital signs findings included: pulse rate: <=50 beats/minute (bpm) and decrease of >=15 bpm, or >=120 bpm and increase of >=15 bpm; systolic blood pressure: <=90 millimeters of mercury (mmHg) and decrease of >=20 mmHg, or >=180 mmHg and increase of >=20 mmHg; diastolic blood pressure: <=50 mmHg and decrease of >=15 mmHg or >=105 mmHg and increase of >=15 mmHg; respiratory rate: <10 breaths/minute; and body temperature >=38.3 degrees centigrade and change of >=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
6. Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline (Day 0), endpoint (Day 336) ]
   ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
7. Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results [ Time Frame: Baseline (Day 0), endpoint (Day 336) ]
   Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant 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). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
8. Number of Participants With Injection Site Reactions [ Time Frame: Baseline (Day -28 to Day -1), Month 12 ]
   Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
9. Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) [ Time Frame: Baseline (Day -28 to Day -1), Month 12 ]
   eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was 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 was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.

Other Outcome Measures:

1. Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12 [ Time Frame: Baseline (Day -28 to Day -1), Month 12 ]
   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 (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was 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 were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. Change was calculated as post-baseline value - baseline value.
2. Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12 [ Time Frame: Baseline (Day -28 to Day -1), Month 12 ]
   Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value.
3. Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12 [ Time Frame: Baseline (Day -28 to Day -1), Month 12 ]
   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 (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was 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 were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period) * 28.
4. Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period [ Time Frame: Baseline (Day -28 to Day -1), Month 12 ]
   Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

Teva Investigational Site 13628

Birmingham, Alabama, United States, 35211

Teva Investigational Site 13577

Birmingham, Alabama, United States, 35216

United States, Arizona

Teva Investigational Site 13606

Phoenix, Arizona, United States, 85018

Teva Investigational Site 13579

Phoenix, Arizona, United States, 85023

United States, Arkansas

Teva Investigational Site 13602

Little Rock, Arkansas, United States, 72205

United States, California

Teva Investigational Site 13568

Encino, California, United States, 91316

Teva Investigational Site 13546

Fullerton, California, United States, 92835

Teva Investigational Site 13540

Long Beach, California, United States, 90806

Teva Investigational Site 13632

Redlands, California, United States, 92374

Teva Investigational Site 13571

Redondo Beach, California, United States, 90277

Teva Investigational Site 13573

San Diego, California, United States, 92103

Teva Investigational Site 13538

Santa Monica, California, United States, 90404

Teva Investigational Site 13594

Santa Rosa, California, United States, 95405

Teva Investigational Site 13595

Walnut Creek, California, United States, 94598

United States, Colorado

Teva Investigational Site 13629

Aurora, Colorado, United States, 80014

Teva Investigational Site 13557

Boulder, Colorado, United States, 80301

Teva Investigational Site 13593

Colorado Springs, Colorado, United States, 80918

Teva Investigational Site 13633

Denver, Colorado, United States, 80210

Teva Investigational Site 13612

Denver, Colorado, United States, 80239

Teva Investigational Site 13631

Englewood, Colorado, United States, 80113

United States, Connecticut

Teva Investigational Site 13563

East Hartford, Connecticut, United States, 06118

Teva Investigational Site 13550

Stamford, Connecticut, United States, 06905

United States, Florida

Teva Investigational Site 13635

Bradenton, Florida, United States, 34201

Teva Investigational Site 13597

Gainesville, Florida, United States, 32607

Teva Investigational Site 13607

Hialeah, Florida, United States, 33012

Teva Investigational Site 13559

Jacksonville, Florida, United States, 32205

Teva Investigational Site 13584

Ocala, Florida, United States, 34471

Teva Investigational Site 13587

Orlando, Florida, United States, 32806

Teva Investigational Site 13567

Palm Beach Gardens, Florida, United States, 33410

Teva Investigational Site 13553

Pembroke Pines, Florida, United States, 33026

Teva Investigational Site 13616

Pinellas Park, Florida, United States, 33781

United States, Georgia

Teva Investigational Site 13620

Atlanta, Georgia, United States, 30312

Teva Investigational Site 13537

Atlanta, Georgia, United States, 30342

United States, Idaho

Teva Investigational Site 13604

Boise, Idaho, United States, 83642

United States, Illinois

Teva Investigational Site 13585

Chicago, Illinois, United States, 60607

Teva Investigational Site 13621

Chicago, Illinois, United States, 60654

Teva Investigational Site 13627

Evanston, Illinois, United States, 60201

United States, Indiana

Teva Investigational Site 13596

Indianapolis, Indiana, United States, 46254

United States, Kansas

Teva Investigational Site 13617

Wichita, Kansas, United States, 67207

Teva Investigational Site 13598

Wichita, Kansas, United States, 67211

United States, Kentucky

Teva Investigational Site 13566

Louisville, Kentucky, United States, 40207

United States, Louisiana

Teva Investigational Site 13603

Metairie, Louisiana, United States, 70006

United States, Maryland

Teva Investigational Site 13582

Pikesville, Maryland, United States, 21208

United States, Massachusetts

Teva Investigational Site 13590

Boston, Massachusetts, United States, 02131

Teva Investigational Site 13589

New Bedford, Massachusetts, United States, 02301

Teva Investigational Site 13543

Watertown, Massachusetts, United States, 02472

United States, Michigan

Teva Investigational Site 13539

Ann Arbor, Michigan, United States, 48104

United States, Minnesota

Teva Investigational Site 13542

Golden Valley, Minnesota, United States, 55422

United States, Missouri

Teva Investigational Site 13534

Kansas City, Missouri, United States, 64114

Teva Investigational Site 13619

Saint Louis, Missouri, United States, 63141

Teva Investigational Site 13536

Springfield, Missouri, United States, 65807

United States, Nebraska

Teva Investigational Site 13618

Fremont, Nebraska, United States, 68025

United States, Nevada

Teva Investigational Site 13605

Las Vegas, Nevada, United States, 89106

United States, New Hampshire

Teva Investigational Site 13578

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

Teva Investigational Site 13575

Martinsville, New Jersey, United States, 08836

Teva Investigational Site 13622

Princeton, New Jersey, United States, 08540

United States, New Mexico

Teva Investigational Site 13588

Albuquerque, New Mexico, United States, 87102

United States, New York

Teva Investigational Site 13576

Amherst, New York, United States, 14226

Teva Investigational Site 13565

Plainview, New York, United States, 11803

United States, North Carolina

Teva Investigational Site 13544

Greensboro, North Carolina, United States, 27405

Teva Investigational Site 13574

Greensboro, North Carolina, United States, 27408

Teva Investigational Site 13545

Raleigh, North Carolina, United States, 27612

United States, Ohio

Teva Investigational Site 13609

Akron, Ohio, United States, 44311

Teva Investigational Site 13625

Akron, Ohio, United States, 44311

Teva Investigational Site 13634

Akron, Ohio, United States, 44311

Teva Investigational Site 13533

Cincinnati, Ohio, United States, 45227

Teva Investigational Site 13624

Cincinnati, Ohio, United States, 45249

Teva Investigational Site 13569

Cleveland, Ohio, United States, 44195

Teva Investigational Site 13626

Columbus, Ohio, United States, 43212

United States, Oklahoma

Teva Investigational Site 13561

Oklahoma City, Oklahoma, United States, 73112

United States, Oregon

Teva Investigational Site 13601

Eugene, Oregon, United States, 97401

United States, Pennsylvania

Teva Investigational Site 13591

Jenkintown, Pennsylvania, United States, 19046

Teva Investigational Site 13554

Philadelphia, Pennsylvania, United States, 19107

Teva Investigational Site 13608

Uniontown, Pennsylvania, United States, 15401

United States, South Carolina

Teva Investigational Site 13615

Greer, South Carolina, United States, 29650

Teva Investigational Site 13556

Mount Pleasant, South Carolina, United States, 29464

United States, Tennessee

Teva Investigational Site 13560

Bristol, Tennessee, United States, 37620

Teva Investigational Site 13551

Memphis, Tennessee, United States, 38119

Teva Investigational Site 13532

Nashville, Tennessee, United States, 37203

Teva Investigational Site 13552

Nashville, Tennessee, United States, 37203

United States, Texas

Teva Investigational Site 13541

Austin, Texas, United States, 78731

Teva Investigational Site 13623

Dallas, Texas, United States, 75214

Teva Investigational Site 13611

Plano, Texas, United States, 75024

Teva Investigational Site 13572

San Antonio, Texas, United States, 78229

United States, Utah

Teva Investigational Site 13614

Murray, Utah, United States, 84107

Teva Investigational Site 13581

West Jordan, Utah, United States, 84088

United States, Virginia

Teva Investigational Site 13630

Virginia Beach, Virginia, United States, 23454

United States, Washington

Teva Investigational Site 13564

Seattle, Washington, United States, 98105

Teva Investigational Site 13586

Seattle, Washington, United States, 98105

United States, West Virginia

Teva Investigational Site 13600

Morgantown, West Virginia, United States, 26506

Canada, Ontario

Teva Investigational Site 11124

Hamilton, Ontario, Canada, L8N 1Y2

Teva Investigational Site 11122

Newmarket, Ontario, Canada, L3Y5G8

Canada

Teva Investigational Site 11120

Calgary, Canada, T3M 1M4

Teva Investigational Site 11121

Montreal, Canada, H2W 1V1

Teva Investigational Site 11123

Sarnia, Canada, N7T 4X3

Czechia

Teva Investigational Site 54144

Brno, Czechia, 602 00

Teva Investigational Site 54141

Kunratice, Czechia, 14800

Teva Investigational Site 54145

Pardubice, Czechia, 53002

Teva Investigational Site 54142

Prague 4, Czechia, 140 59

Teva Investigational Site 54146

Praha 3, Czechia, 130 00

Teva Investigational Site 54143

Praha, Czechia, 100 00

Finland

Teva Investigational Site 40018

Helsinki, Finland, 00180

Teva Investigational Site 40017

Helsinki, Finland, 00930

Teva Investigational Site 40016

Turku, Finland, 20100

Israel

Teva Investigational Site 80096

Holon, Israel, 58100

Teva Investigational Site 80099

Jerusalem, Israel, 9112001

Teva Investigational Site 80098

Nahariya, Israel, 221001

Teva Investigational Site 80097

Netanya, Israel, 4244916

Teva Investigational Site 80100

Ramat Gan, Israel, 5265601

Teva Investigational Site 80095

Tel Aviv, Israel, 6423906

Japan

Teva Investigational Site 84072

Chofu-shi, Japan, 182-0006

Teva Investigational Site 84066

Kagoshima-shi, Japan, 892-0844

Teva Investigational Site 84069

Kai, Japan, 400-0124

Teva Investigational Site 84073

Kawasaki, Japan, 211-8588

Teva Investigational Site 84067

Kyoto, Japan, 600-8811

Teva Investigational Site 84062

Osaka-shi, Japan, 556-0015

Teva Investigational Site 84070

Saitama, Japan, 338-8577

Teva Investigational Site 84061

Sendai-shi, Japan, 982-0014

Teva Investigational Site 84063

Shinjuku-ku, Japan, 160-8582

Teva Investigational Site 84068

Shizuoka, Japan, 4200-853

Teva Investigational Site 84065

Tochigi, Japan, 321-0293

Teva Investigational Site 84064

Tokyo, Japan, 182-0006

Teva Investigational Site 84071

Toyonaka, Japan

Poland

Teva Investigational Site 53364

Krakow, Poland, 31-523

Teva Investigational Site 53363

Krakow, Poland, 33-332

Teva Investigational Site 53366

Lublin, Poland, 20-022

Teva Investigational Site 53365

Poznan, Poland, 60-529

Teva Investigational Site 53367

Warsaw, Poland, 04-730

Russian Federation

Teva Investigational Site 50399

Kazan, Russian Federation, 420012

Teva Investigational Site 50395

Kazan, Russian Federation, 420021

Teva Investigational Site 50394

Moscow, Russian Federation, 121467

Teva Investigational Site 50400

Moscow, Russian Federation, 129128

Teva Investigational Site 50398

Nizhniy Novgorod, Russian Federation, 603126

Teva Investigational Site 50396

Nizhniy Novgorod, Russian Federation, 603137

Teva Investigational Site 50397

Ufa, Russian Federation, 450007

Spain

Teva Investigational Site 31207

Madrid, Spain, 28046

Teva Investigational Site 31208

Pamplona, Spain, 31008

Teva Investigational Site 31205

Valladolid, Spain, 47003

Teva Investigational Site 31206

Zaragoza, Spain, 50009

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Teva Medical Expert, MD; Teva Pharmaceuticals USA

  Study Documents (Full-Text)

Documents provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. ):

Study Protocol  [PDF] March 30, 2016

Statistical Analysis Plan  [PDF] June 13, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT02638103
• Other Study ID Numbers: TV48125-CNS-30051; 2015-004550-18 ( EudraCT Number )
• First Posted: December 22, 2015
• Results First Posted: August 28, 2019
• Last Update Posted: February 28, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases