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

Primary Purpose

Migraine

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fremanezumab

Placebo

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Fremanezumab 675 mg/placebo/placebo

Fremanezumab 675/225/225 mg

Arm Description

Matching 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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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

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

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

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

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.

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.

Full Information

NCT ID

NCT02621931

First Posted

December 2, 2015

Last Updated

November 6, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02621931

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

March 22, 2016 (Actual)

Primary Completion Date

April 11, 2017 (Actual)

Study Completion Date

April 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching Placebo

Arm Title

Fremanezumab 675 mg/placebo/placebo

Arm Type

Experimental

Arm Description

Arm Title

Fremanezumab 675/225/225 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fremanezumab

Other Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Day 1 to Week 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline, 12 weeks

Title

Electrocardiogram (ECG) Findings Shifts From Baseline to Overall

Description

Time Frame

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

Title

Participants With Vital Signs Potentially Clinically Significant Abnormal Values

Description

Time Frame

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

Title

Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results

Description

Time Frame

Treatment Days 28, 56 and 84 (or endpoint)

Title

Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results

Description

Time Frame

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

Title

Prothrombin Time Shifts From Baseline to Endpoint

Description

Time Frame

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

Title

Injection Site Reaction Adverse Events

Description

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.

Time Frame

Day 1 to Week 12

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 13628

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Teva Investigational Site 13577

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Teva Investigational Site 13577

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 13628

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 13606

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Teva Investigational Site 13579

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Teva Investigational Site 13579

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 13606

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 13602

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Teva Investigational Site 13602

City

Little Rock

State/Province

Arkansas

Country

United States

Facility Name

Teva Investigational Site 13568

City

Encino

State/Province

California

ZIP/Postal Code

91316

Country

United States

Facility Name

Teva Investigational Site 13568

City

Encino

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13546

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Teva Investigational Site 13546

City

Fullerton

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13540

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Teva Investigational Site 13540

City

Long Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13632

City

Redlands

State/Province

California

ZIP/Postal Code

92374

Country

United States

Facility Name

Teva Investigational Site 13632

City

Redlands

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13571

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Teva Investigational Site 13571

City

Redondo Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13573

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Teva Investigational Site 13573

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13538

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Teva Investigational Site 13538

City

Santa Monica

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13594

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

Teva Investigational Site 13594

City

Santa Rosa

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13595

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Teva Investigational Site 13595

City

Walnut Creek

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 13629

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80014

Country

United States

Facility Name

Teva Investigational Site 13629

City

Aurora

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 13557

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

Teva Investigational Site 13557

City

Boulder

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 13593

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80918

Country

United States

Facility Name

Teva Investigational Site 13593

City

Colorado Springs

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 13633

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Teva Investigational Site 13612

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

Teva Investigational Site 13612

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 13633

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 13631

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Teva Investigational Site 13631

City

Englewood

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 13563

City

East Hartford

State/Province

Connecticut

ZIP/Postal Code

06118

Country

United States

Facility Name

Teva Investigational Site 13563

City

East Hartford

State/Province

Connecticut

Country

United States

Facility Name

Teva Investigational Site 13550

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Teva Investigational Site 13550

City

Stamford

State/Province

Connecticut

Country

United States

Facility Name

Teva Investigational Site 13635

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34201

Country

United States

Facility Name

Teva Investigational Site 13635

City

Bradenton

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13597

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Teva Investigational Site 13597

City

Gainesville

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13607

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Teva Investigational Site 13607

City

Hialeah

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13559

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Teva Investigational Site 13559

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13584

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Teva Investigational Site 13584

City

Ocala

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13587

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Teva Investigational Site 13599

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Teva Investigational Site 13551

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13555

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13587

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13599

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13567

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

Teva Investigational Site 13567

City

Palm Beach Gardens

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13553

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Teva Investigational Site 13553

City

Pembroke Pines

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13616

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Teva Investigational Site 13616

City

Pinellas Park

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 13620

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30312

Country

United States

Facility Name

Teva Investigational Site 13537

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Teva Investigational Site 13537

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 13620

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 13604

City

Boise

State/Province

Idaho

Country

United States

Facility Name

Teva Investigational Site 13604

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Teva Investigational Site 13585

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Teva Investigational Site 13621

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60654

Country

United States

Facility Name

Teva Investigational Site 13585

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Teva Investigational Site 13621

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Teva Investigational Site 13627

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Teva Investigational Site 13627

City

Evanston

State/Province

Illinois

Country

United States

Facility Name

Teva Investigational Site 13596

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46254

Country

United States

Facility Name

Teva Investigational Site 13596

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 13617

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Teva Investigational Site 13598

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67211

Country

United States

Facility Name

Teva Investigational Site 13598

City

Wichita

State/Province

Kansas

Country

United States

Facility Name

Teva Investigational Site 13617

City

Wichita

State/Province

Kansas

Country

United States

Facility Name

Teva Investigational Site 13566

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Teva Investigational Site 13566

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

Teva Investigational Site 13603

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Teva Investigational Site 13603

City

Metairie

State/Province

Louisiana

Country

United States

Facility Name

Teva Investigational Site 13582

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 13582

City

Pikesville

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Teva Investigational Site 13590

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02131

Country

United States

Facility Name

Teva Investigational Site 13590

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 13589

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

Teva Investigational Site 13589

City

New Bedford

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 13543

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Teva Investigational Site 13543

City

Watertown

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 13539

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Teva Investigational Site 13539

City

Ann Arbor

State/Province

Michigan

Country

United States

Facility Name

Teva Investigational Site 13542

City

Golden Valley

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Teva Investigational Site 13542

City

Golden Valley

State/Province

Minnesota

Country

United States

Facility Name

Teva Investigational Site 13534

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Teva Investigational Site 13534

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 13619

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Teva Investigational Site 13619

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 13536

City

Springfield

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 13618

City

Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

Country

United States

Facility Name

Teva Investigational Site 13618

City

Fremont

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 13605

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Teva Investigational Site 13605

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

Teva Investigational Site 13578

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Teva Investigational Site 13578

City

Lebanon

State/Province

New Hampshire

Country

United States

Facility Name

Teva Investigational Site 13575

City

Martinsville

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 13575

City

Raritan

State/Province

New Jersey

ZIP/Postal Code

08869

Country

United States

Facility Name

Teva Investigational Site 13588

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Teva Investigational Site 13588

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

Teva Investigational Site 13576

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Teva Investigational Site 13576

City

Amherst

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 13565

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Teva Investigational Site 13565

City

Plainview

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 13544

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Teva Investigational Site 13574

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Teva Investigational Site 13544

City

Greensboro

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 13574

City

Greensboro

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 13545

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Teva Investigational Site 13545

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 13609

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Teva Investigational Site 13634

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Teva Investigational Site 13609

City

Akron

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 13634

City

Akron

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 13533

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Teva Investigational Site 13624

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Teva Investigational Site 13533

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 13624

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 13569

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Teva Investigational Site 13569

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 13626

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Teva Investigational Site 13626

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 13625

City

Mogadore

State/Province

Ohio

ZIP/Postal Code

44260

Country

United States

Facility Name

Teva Investigational Site 13625

City

Mogadore

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 13561

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Teva Investigational Site 13561

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 13601

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Teva Investigational Site 13601

City

Eugene

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 13591

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Teva Investigational Site 13591

City

Jenkintown

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 13554

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Teva Investigational Site 13554

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 13608

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

Teva Investigational Site 13608

City

Uniontown

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 13615

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Teva Investigational Site 13615

City

Greer

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 13556

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Teva Investigational Site 13556

City

Mount Pleasant

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 13560

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Teva Investigational Site 13560

City

Bristol

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 13532

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Teva Investigational Site 13552

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Teva Investigational Site 13532

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 13552

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 13541

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Teva Investigational Site 13541

City

Austin

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 13623

City

Dallas

State/Province

Texas

ZIP/Postal Code

75214

Country

United States

Facility Name

Teva Investigational Site 13623

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 13611

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Teva Investigational Site 13611

City

Plano

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 13572

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Teva Investigational Site 13572

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 13614

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Teva Investigational Site 13614

City

Murray

State/Province

Utah

Country

United States

Facility Name

Teva Investigational Site 13581

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

Teva Investigational Site 13581

City

West Jordan

State/Province

Utah

Country

United States

Facility Name

Teva Investigational Site 13630

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Teva Investigational Site 13630

City

Virginia Beach

State/Province

Virginia

Country

United States

Facility Name

Teva Investigational Site 13564

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Teva Investigational Site 13586

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Teva Investigational Site 13564

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 13586

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 13600

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Teva Investigational Site 13600

City

Morgantown

State/Province

West Virginia

Country

United States

Facility Name

Teva Investigational Site 11124

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Teva Investigational Site 11124

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

Teva Investigational Site 11120

City

Calgary

ZIP/Postal Code

T3M 1M4

Country

Canada

Facility Name

Teva Investigational Site 11120

City

Calgary

Country

Canada

Facility Name

Teva Investigational Site 11121

City

Montreal

ZIP/Postal Code

H2W 1V1

Country

Canada

Facility Name

Teva Investigational Site 11121

City

Montreal

Country

Canada

Facility Name

Teva Investigational Site 11122

City

Newmarket

ZIP/Postal Code

L3Y5G8

Country

Canada

Facility Name

Teva Investigational Site 11122

City

Newmarket

Country

Canada

Facility Name

Teva Investigational Site 11123

City

Sarnia

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Teva Investigational Site 11123

City

Sarnia

Country

Canada

Facility Name

Teva Investigational Site 54144

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Teva Investigational Site 54144

City

Brno

Country

Czechia

Facility Name

Teva Investigational Site 54141

City

Kunratice

ZIP/Postal Code

14800

Country

Czechia

Facility Name

Teva Investigational Site 54141

City

Kunratice

Country

Czechia

Facility Name

Teva Investigational Site 54145

City

Pardubice

ZIP/Postal Code

53002

Country

Czechia

Facility Name

Teva Investigational Site 54145

City

Pardubice

Country

Czechia

Facility Name

Teva Investigational Site 54142

City

Prague 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Teva Investigational Site 54142

City

Prague 4

Country

Czechia

Facility Name

Teva Investigational Site 54146

City

Praha 3

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Teva Investigational Site 54146

City

Praha 3

Country

Czechia

Facility Name

Teva Investigational Site 54143

City

Praha

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Teva Investigational Site 54143

City

Praha

Country

Czechia

Facility Name

Teva Investigational Site 40018

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Teva Investigational Site 40017

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

Teva Investigational Site 40017

City

Helsinki

Country

Finland

Facility Name

Teva Investigational Site 40018

City

Helsinki

Country

Finland

Facility Name

Teva Investigational Site 40016

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Teva Investigational Site 40016

City

Turku

Country

Finland

Facility Name

Teva Investigational Site 80096

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Teva Investigational Site 80096

City

Holon

Country

Israel

Facility Name

Teva Investigational Site 80099

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Teva Investigational Site 80099

City

Jerusalem

Country

Israel

Facility Name

Teva Investigational Site 80098

City

Nahariya

ZIP/Postal Code

221001

Country

Israel

Facility Name

Teva Investigational Site 80097

City

Netanya

ZIP/Postal Code

4244916

Country

Israel

Facility Name

Teva Investigational Site 80097

City

Netanya

Country

Israel

Facility Name

Teva Investigational Site 80100

City

Ramat Gan

ZIP/Postal Code

5262160

Country

Israel

Facility Name

Teva Investigational Site 80100

City

Ramat Gan

Country

Israel

Facility Name

Teva Investigational Site 80095

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Teva Investigational Site 84072

City

Chofu-shi

ZIP/Postal Code

182-0006

Country

Japan

Facility Name

Teva Investigational Site 84064

City

Chofu-shi

Country

Japan

Facility Name

Teva Investigational Site 84072

City

Chofu-shi

Country

Japan

Facility Name

Teva Investigational Site 84066

City

Kagoshima-shi

Country

Japan

Facility Name

Teva Investigational Site 84066

City

Kagoshima

ZIP/Postal Code

892-0844

Country

Japan

Facility Name

Teva Investigational Site 84069

City

Kai-shi

Country

Japan

Facility Name

Teva Investigational Site 84069

City

Kai

ZIP/Postal Code

400-0124

Country

Japan

Facility Name

Teva Investigational Site 84073

City

Kawasaki-shi

Country

Japan

Facility Name

Teva Investigational Site 84073

City

Kawasaki

ZIP/Postal Code

211-8588

Country

Japan

Facility Name

Teva Investigational Site 84067

City

Kyoto

ZIP/Postal Code

600-8811

Country

Japan

Facility Name

Teva Investigational Site 84067

City

Kyoto

Country

Japan

Facility Name

Teva Investigational Site 84062

City

Osaka-shi

ZIP/Postal Code

556-0015

Country

Japan

Facility Name

Teva Investigational Site 84062

City

Osaka-shi

Country

Japan

Facility Name

Teva Investigational Site 84070

City

Saitama-shi

Country

Japan

Facility Name

Teva Investigational Site 84070

City

Saitama

ZIP/Postal Code

338-8577

Country

Japan

Facility Name

Teva Investigational Site 84061

City

Sendai-shi

ZIP/Postal Code

982-0014

Country

Japan

Facility Name

Teva Investigational Site 84061

City

Sendai-shi

Country

Japan

Facility Name

Teva Investigational Site 84065

City

Shimotsuma

Country

Japan

Facility Name

Teva Investigational Site 84068

City

Shizuoka-shi

Country

Japan

Facility Name

Teva Investigational Site 84068

City

Shizuoka

ZIP/Postal Code

4200-853

Country

Japan

Facility Name

Teva Investigational Site 84065

City

Tochigi

ZIP/Postal Code

321-0293

Country

Japan

Facility Name

Teva Investigational Site 84064

City

Tokyo

ZIP/Postal Code

182-0006

Country

Japan

Facility Name

Teva Investigational Site 84071

City

Toyonaka-shi

Country

Japan

Facility Name

Teva Investigational Site 84071

City

Toyonaka

Country

Japan

Facility Name

Teva Investigational Site 53364

City

Krakow

ZIP/Postal Code

31-523

Country

Poland

Facility Name

Teva Investigational Site 53363

City

Krakow

ZIP/Postal Code

33-332

Country

Poland

Facility Name

Teva Investigational Site 53363

City

Krakow

Country

Poland

Facility Name

Teva Investigational Site 53364

City

Krakow

Country

Poland

Facility Name

Teva Investigational Site 53366

City

Lublin

ZIP/Postal Code

20-022

Country

Poland

Facility Name

Teva Investigational Site 53366

City

Lublin

Country

Poland

Facility Name

Teva Investigational Site 53365

City

Poznan

ZIP/Postal Code

60-529

Country

Poland

Facility Name

Teva Investigational Site 53365

City

Poznan

Country

Poland

Facility Name

Teva Investigational Site 53367

City

Warsaw

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Teva Investigational Site 53367

City

Warsaw

Country

Poland

Facility Name

Teva Investigational Site 50399

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Teva Investigational Site 50395

City

Kazan

ZIP/Postal Code

420021

Country

Russian Federation

Facility Name

Teva Investigational Site 50395

City

Kazan

Country

Russian Federation

Facility Name

Teva Investigational Site 50399

City

Kazan

Country

Russian Federation

Facility Name

Teva Investigational Site 50394

City

Moscow

ZIP/Postal Code

121467

Country

Russian Federation

Facility Name

Teva Investigational Site 50400

City

Moscow

ZIP/Postal Code

129128

Country

Russian Federation

Facility Name

Teva Investigational Site 50394

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 50400

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 50398

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Teva Investigational Site 50396

City

Nizhniy Novgorod

ZIP/Postal Code

603137

Country

Russian Federation

Facility Name

Teva Investigational Site 50396

City

Nizhniy Novgorod

Country

Russian Federation

Facility Name

Teva Investigational Site 50398

City

Nizhniy Novgorod

Country

Russian Federation

Facility Name

Teva Investigational Site 50397

City

Ufa

ZIP/Postal Code

450007

Country

Russian Federation

Facility Name

Teva Investigational Site 50397

City

Ufa

Country

Russian Federation

Facility Name

Teva Investigational Site 31207

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Teva Investigational Site 31207

City

Madrid

Country

Spain

Facility Name

Teva Investigational Site 31208

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Teva Investigational Site 31208

City

Pamplona

Country

Spain

Facility Name

Teva Investigational Site 31205

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Name

Teva Investigational Site 31205

City

Valladolid

Country

Spain

Facility Name

Teva Investigational Site 31206

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Teva Investigational Site 31206

City

Zaragoza

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

36038833

Citation

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.

Results Reference

derived

PubMed Identifier

35331009

Citation

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.

Results Reference

derived

PubMed Identifier

34819017

Citation

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. Erratum In: J Headache Pain. 2022 May 17;23(1):57.

Results Reference

derived

PubMed Identifier

33413075

Citation

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.

Results Reference

derived

PubMed Identifier

32958075

Citation

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.

Results Reference

derived

PubMed Identifier

32747522

Citation

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.

Results Reference

derived

PubMed Identifier

31675102

Citation

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.

Results Reference

derived

PubMed Identifier

29171818

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial