MedPath

An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

Phase 3
Completed
Conditions
Migraine Prophylaxis
Interventions
Drug: Placebo
Registration Number
NCT03308968
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
838
Inclusion Criteria
  • The participant has a diagnosis of migraine with onset at ≤50 years of age.

  • Body weight ≥45 kilograms.

  • The participant has a history of migraine for ≥12 months prior to screening.

  • Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP)

  • Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [that is; vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP).

    • Additional criteria apply, please contact the investigator for more information.
Exclusion Criteria
  • At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.

  • Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.

  • The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.

  • The participant uses triptans/ergots as preventive therapies for migraine.

  • Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed.

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboFremanezumabDouble-blind (DB) period: Participants with CM or EM will receive 3 injections of placebo 1.5 milliliters (mL) SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. Open-label (OL) period: Participants with CM or EM will receive fremanezumab (TEV-48125) 225 milligrams (mg) SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Fremanezumab QuarterlyFremanezumabDB period: Participants with CM or EM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Fremanezumab MonthlyFremanezumabDB period: Participants with CM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Fremanezumab MonthlyPlaceboDB period: Participants with CM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
PlaceboPlaceboDouble-blind (DB) period: Participants with CM or EM will receive 3 injections of placebo 1.5 milliliters (mL) SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. Open-label (OL) period: Participants with CM or EM will receive fremanezumab (TEV-48125) 225 milligrams (mg) SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Fremanezumab QuarterlyPlaceboDB period: Participants with CM or EM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.
Primary Outcome Measures
NameTimeMethod
DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of FremanezumabBaseline (Day -28 to Day -1), up to Week 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 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 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.

Secondary Outcome Measures
NameTimeMethod
DB Period: Percentage of Participants Reaching at Least 50 Percent (%) Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of FremanezumabBaseline (Day -28 to Day-1), up to Week 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 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 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.

DB Period: Number of Participants With Adverse Events (AEs) and Who Did Not Complete the Study Due to AEsBaseline (Day 0) up to Week 12

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.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry ResultsWeek 12 up to Week 24

Criteria for potentially clinically significant abnormal serum chemistry values included: ALT, AST, ALP, GGT, and LDH (U/L): ≥3\*ULN; BUN: ≥10.71 mmol/L; creatinine: ≥177 µmol/L; bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Percentage of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of FremanezumabBaseline (Day -28 to Day-1), up to Week 4

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 meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours 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.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology ResultsWeek 12 up to Week 24

Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: \<115 g/L (in men) or ≤95 g/L (in women), hematocrit: \<0.37 L/L (in men) or \<0.32 L/L (in women), leukocytes: ≥20\*10\^9/L or ≤3\*10\^9/L, eosinophils: \>=10%, platelets: ≥700\*10\^9/L or ≤75\*10\^9/L, and ANC: ≤1\*10\^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test ResultsBaseline up to Week 12

Criteria for potentially clinically significant abnormal coagulation values included: prothrombin international normalized ratio (INR): greater than (\>) 1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

OL Period: Number of Participants With Shift From Baseline to Week 24 in ECG ParametersBaseline, Week 24

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 - Week 24 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.

DB Period: Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of FremanezumabBaseline (Day -28 to Day -1), up to Week 12

Baseline data and the mean change from baseline in the monthly average number of days of use of any acute headache medications during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment\*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry ResultsBaseline up to Week 12

Criteria for potentially clinically significant abnormal serum chemistry values included: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) (units/liter \[U/L\]): greater than or equal to (≥) 3\*upper limit of normal (ULN); Blood Urea Nitrogen (BUN): ≥10.71 millimoles/liter (mmol/L); creatinine: ≥177 micromoles/liter (µmol/L); bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology ResultsBaseline up to Week 12

Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: less than (\<) 115 grams/liter (g/L) (in men) or less than or equal to (≤) 95 g/L (in women), hematocrit: \<0.37 L/L (in men) or \<0.32 L/L (in women), leukocytes: ≥20\*10\^9/L or ≤3\*10\^9/L, eosinophils: \>=10%, platelets: ≥700\*10\^9/L or ≤75\*10\^9/L, and absolute neutrophil count (ANC): ≤1\*10\^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period After the First Dose of FremanezumabBaseline (Day -28 to Day -1), up to Week 4

A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). 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. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment\*migraine classification as fixed effects, and baseline number of headache days of at least moderate severity and years since onset of migraines as covariates.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs ValuesWeek 12 up to Week 24

Criteria for potentially clinically significant abnormal vital signs values included: pulse rate: ≤50 bpm and decrease of ≥15 bpm, or ≥120 bpm and increase of ≥15 bpm; systolic blood pressure: ≤90 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 celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of FremanezumabBaseline (Day -28 to Day -1), up to Week 12

A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). 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. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment\*migraine classification as fixed effects and baseline number of headache days of at least moderate severity and years since onset of migraine as covariates.

DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of FremanezumabBaseline (Day -28 to Day -1), up to Week 4

A migraine day was defined as when at least 1 of following occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day demonstrating a headache of any duration that was treated with migraine-specific medications. 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. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment\*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.

OL Period: Number of Participants With AEs and Who Did Not Complete the Study Due to AEsWeek 12 up to Week 24

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.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests ResultsBaseline up to Week 12

Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (milligrams/deciliter \[mg/dL\]): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥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.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs ValuesBaseline up to Week 12

Criteria for potentially clinically significant abnormal vital signs values 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 celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants With Shift From Baseline to Week 12 in Electrocardiogram (ECG) ParametersBaseline, Week 12

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 - Week 12 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.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test ResultsWeek 12 up to Week 24

Criteria for potentially clinically significant abnormal coagulation values included: prothrombin INR: \>1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests ResultsWeek 12 up to Week 24

Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (mg/dL): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥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.

DB Period: Number of Participants Who Received Concomitant Medications for Adverse EventsBaseline up to Week 12

Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.

OL Period: Number of Participants Who Received Concomitant Medications for Adverse EventsWeek 12 up to Week 24

Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.

Trial Locations

Locations (113)

Teva Investigational Site 14760

🇺🇸

Decatur, Georgia, United States

Teva Investigational Site 14739

🇺🇸

San Diego, California, United States

Teva Investigational Site 42054

🇸🇪

Stockholm, Sweden

Teva Investigational Site 14749

🇺🇸

Colorado Springs, Colorado, United States

Teva Investigational Site 39049

🇩🇰

Arhus, Denmark

Teva Investigational Site 14746

🇺🇸

Omaha, Nebraska, United States

Teva Investigational Site 14743

🇺🇸

Nashville, Tennessee, United States

Teva Investigational Site 14729

🇺🇸

Long Beach, California, United States

Teva Investigational Site 14742

🇺🇸

Huntsville, Alabama, United States

Teva Investigational Site 14843

🇺🇸

Santa Monica, California, United States

Teva Investigational Site 14758

🇺🇸

Maitland, Florida, United States

Teva Investigational Site 14737

🇺🇸

Meridian, Idaho, United States

Teva Investigational Site 14730

🇺🇸

Chicago, Illinois, United States

Teva Investigational Site 14740

🇺🇸

Evanston, Illinois, United States

Teva Investigational Site 14747

🇺🇸

Pikesville, Maryland, United States

Teva Investigational Site 14734

🇺🇸

Watertown, Massachusetts, United States

Teva Investigational Site 14748

🇺🇸

Plymouth, Minnesota, United States

Teva Investigational Site 14754

🇺🇸

Berlin, New Jersey, United States

Teva Investigational Site 14752

🇺🇸

Albuquerque, New Mexico, United States

Teva Investigational Site 14753

🇺🇸

Amherst, New York, United States

Teva Investigational Site 14736

🇺🇸

Greensboro, North Carolina, United States

Teva Investigational Site 14741

🇺🇸

Greensboro, North Carolina, United States

Teva Investigational Site 14732

🇺🇸

Raleigh, North Carolina, United States

Teva Investigational Site 14761

🇺🇸

Lincoln, Rhode Island, United States

Teva Investigational Site 14756

🇺🇸

Warwick, Rhode Island, United States

Teva Investigational Site 14745

🇺🇸

Memphis, Tennessee, United States

Teva Investigational Site 14751

🇺🇸

West Jordan, Utah, United States

Teva Investigational Site 37089

🇧🇪

Brussels, Belgium

Teva Investigational Site 37092

🇧🇪

Brugge, Belgium

Teva Investigational Site 37091

🇧🇪

Hasselt, Belgium

Teva Investigational Site 37090

🇧🇪

Liege, Belgium

Teva Investigational Site 39048

🇩🇰

Glostrup, Denmark

Teva Investigational Site 54162

🇨🇿

Brno, Czechia

Teva Investigational Site 54165

🇨🇿

Ostrava-Moravska, Czechia

Teva Investigational Site 54159

🇨🇿

Ostrava, Czechia

Teva Investigational Site 54164

🇨🇿

Prague 4, Czechia

Teva Investigational Site 54160

🇨🇿

Praha 10, Czechia

Teva Investigational Site 54158

🇨🇿

Pardubice, Czechia

Teva Investigational Site 39052

🇩🇰

Ballerup, Denmark

Teva Investigational Site 54166

🇨🇿

Praha 8, Czechia

Teva Investigational Site 54163

🇨🇿

Prague, Czechia

Teva Investigational Site 54161

🇨🇿

Praha 3, Czechia

Teva Investigational Site 54157

🇨🇿

Rychnov nad Kneznou, Czechia

Teva Investigational Site 39051

🇩🇰

Aalborg, Denmark

Teva Investigational Site 39050

🇩🇰

Vejle, Denmark

Teva Investigational Site 40034

🇫🇮

Helsinki, Finland

Teva Investigational Site 40036

🇫🇮

Oulu, Finland

Teva Investigational Site 40033

🇫🇮

Tampere, Finland

Teva Investigational Site 40032

🇫🇮

Turku, Finland

Teva Investigational Site 40037

🇫🇮

Turku, Finland

Teva Investigational Site 35237

🇫🇷

Bron Cedex, France

Teva Investigational Site 35235

🇫🇷

Marseille, France

Teva Investigational Site 35238

🇫🇷

Lille, France

Teva Investigational Site 35240

🇫🇷

Nice, France

Teva Investigational Site 35236

🇫🇷

Voiron, France

Teva Investigational Site 32690

🇩🇪

Berlin, Germany

Teva Investigational Site 32691

🇩🇪

Halle, Germany

Teva Investigational Site 32692

🇩🇪

Goppingen, Germany

Teva Investigational Site 35239

🇫🇷

Strasbourg, France

Teva Investigational Site 32700

🇩🇪

Kiel, Germany

Teva Investigational Site 32699

🇩🇪

Essen, Germany

Teva Investigational Site 32697

🇩🇪

Berlin, Germany

Teva Investigational Site 32694

🇩🇪

Bochum, Germany

Teva Investigational Site 32698

🇩🇪

Hamburg, Germany

Teva Investigational Site 32695

🇩🇪

Konigstein im Taunus, Germany

Teva Investigational Site 32689

🇩🇪

Muenchen, Germany

Teva Investigational Site 30199

🇮🇹

Firenze, Italy

Teva Investigational Site 30204

🇮🇹

Roma, Italy

Teva Investigational Site 32693

🇩🇪

Ulm, Germany

Teva Investigational Site 32701

🇩🇪

Rostock, Germany

Teva Investigational Site 38126

🇳🇱

Amsterdam, Netherlands

Teva Investigational Site 38127

🇳🇱

Blaricum, Netherlands

Teva Investigational Site 38124

🇳🇱

Leiden, Netherlands

Teva Investigational Site 38125

🇳🇱

Tilburg, Netherlands

Teva Investigational Site 53425

🇵🇱

Krakow, Poland

Teva Investigational Site 53420

🇵🇱

Krakow, Poland

Teva Investigational Site 53423

🇵🇱

Warszawa, Poland

Teva Investigational Site 53422

🇵🇱

Lodz, Poland

Teva Investigational Site 53424

🇵🇱

Lodz, Poland

Teva Investigational Site 53418

🇵🇱

Lublin, Poland

Teva Investigational Site 53416

🇵🇱

Poznan, Poland

Teva Investigational Site 31231

🇪🇸

Barcelona, Spain

Teva Investigational Site 31233

🇪🇸

Valencia, Spain

Teva Investigational Site 53419

🇵🇱

Szczecin, Poland

Teva Investigational Site 53417

🇵🇱

Warszawa, Poland

Teva Investigational Site 31226

🇪🇸

Pamplona, Spain

Teva Investigational Site 31229

🇪🇸

Santander, Spain

Teva Investigational Site 31230

🇪🇸

Santiago de Compostela, Spain

Teva Investigational Site 31225

🇪🇸

Valladolid, Spain

Teva Investigational Site 31234

🇪🇸

Sevilla, Spain

Teva Investigational Site 31227

🇪🇸

Valencia, Spain

Teva Investigational Site 42050

🇸🇪

Helsingborg, Sweden

Teva Investigational Site 45017

🇨🇭

Lugano, Switzerland

Teva Investigational Site 42049

🇸🇪

Huddinge, Sweden

Teva Investigational Site 42052

🇸🇪

Stockholm, Sweden

Teva Investigational Site 42051

🇸🇪

Lund, Sweden

Teva Investigational Site 31228

🇪🇸

Zaragoza, Spain

Teva Investigational Site 45018

🇨🇭

Bad Zurzach, Switzerland

Teva Investigational Site 34232

🇬🇧

Hull, United Kingdom

Teva Investigational Site 45016

🇨🇭

Bern, Switzerland

Teva Investigational Site 34231

🇬🇧

Glasgow, United Kingdom

Teva Investigational Site 34230

🇬🇧

Oxford, United Kingdom

Teva Investigational Site 34233

🇬🇧

London, United Kingdom

Teva Investigational Site 34235

🇬🇧

Salford, United Kingdom

Teva Investigational Site 34236

🇬🇧

Stoke-on-Trent, United Kingdom

Teva Investigational Site 31235

🇪🇸

Madrid, Spain

Teva Investigational Site 31236

🇪🇸

Madrid, Spain

Teva Investigational Site 14750

🇺🇸

Fall River, Massachusetts, United States

Teva Investigational Site 40035

🇫🇮

Helsinki, Finland

Teva Investigational Site 14733

🇺🇸

Austin, Texas, United States

Teva Investigational Site 14735

🇺🇸

Louisville, Kentucky, United States

Teva Investigational Site 14731

🇺🇸

Ann Arbor, Michigan, United States

Teva Investigational Site 14738

🇺🇸

Orlando, Florida, United States

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