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

Phase 3

Completed

Conditions: Migraine

Interventions: Drug: Fremanezumab
Drug: Placebo

Registration Number: NCT02638103

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1890

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants	Fremanezumab	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).
TEV-48125 225 mg Monthly: Active Rollover Participants	Fremanezumab	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).
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants	Fremanezumab	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).
TEV-48125 225 mg Monthly: Active Rollover Participants	Placebo	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).
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants	Placebo	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).
TEV-48125 675 mg Quarterly: Active Rollover Participants	Placebo	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).
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants	Placebo	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).
TEV-48125 675 mg Quarterly: Active Rollover Participants	Fremanezumab	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	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.
Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results	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.
Number of Participants With Potentially Clinically Significant Abnormal Hematology Results	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.
Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results	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.
Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values	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.
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters	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.
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results	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.
Number of Participants With Injection Site Reactions	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.
Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (139): Teva Investigational Site 53366
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Lublin, Poland
Teva Investigational Site 53365
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Poznan, Poland
Teva Investigational Site 84061
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Sendai-shi, Japan
Teva Investigational Site 50395
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Kazan, Russian Federation
Teva Investigational Site 84064
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Tokyo, Japan
Teva Investigational Site 84067
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Kyoto, Japan
Teva Investigational Site 84065
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Tochigi, Japan
Teva Investigational Site 50400
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Moscow, Russian Federation
Teva Investigational Site 50396
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Nizhniy Novgorod, Russian Federation
Teva Investigational Site 50397
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Ufa, Russian Federation
Teva Investigational Site 13537
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Atlanta, Georgia, United States
Teva Investigational Site 13596
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Indianapolis, Indiana, United States
Teva Investigational Site 13624
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Cincinnati, Ohio, United States
Teva Investigational Site 13564
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Seattle, Washington, United States
Teva Investigational Site 13586
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Seattle, Washington, United States
Teva Investigational Site 13572
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San Antonio, Texas, United States
Teva Investigational Site 13594
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Santa Rosa, California, United States
Teva Investigational Site 13612
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Denver, Colorado, United States
Teva Investigational Site 13584
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Ocala, Florida, United States
Teva Investigational Site 13553
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Pembroke Pines, Florida, United States
Teva Investigational Site 13621
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Chicago, Illinois, United States
Teva Investigational Site 13603
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Metairie, Louisiana, United States
Teva Investigational Site 13582
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Pikesville, Maryland, United States
Teva Investigational Site 13589
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New Bedford, Massachusetts, United States
Teva Investigational Site 13543
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Watertown, Massachusetts, United States
Teva Investigational Site 13542
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Golden Valley, Minnesota, United States
Teva Investigational Site 13619
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Saint Louis, Missouri, United States
Teva Investigational Site 13618
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Fremont, Nebraska, United States
Teva Investigational Site 13605
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Las Vegas, Nevada, United States
Teva Investigational Site 13578
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Lebanon, New Hampshire, United States
Teva Investigational Site 13575
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Martinsville, New Jersey, United States
Teva Investigational Site 13622
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Princeton, New Jersey, United States
Teva Investigational Site 13576
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Amherst, New York, United States
Teva Investigational Site 13565
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Plainview, New York, United States
Teva Investigational Site 13574
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Greensboro, North Carolina, United States
Teva Investigational Site 13625
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Akron, Ohio, United States
Teva Investigational Site 13533
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Cincinnati, Ohio, United States
Teva Investigational Site 13626
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Columbus, Ohio, United States
Teva Investigational Site 13601
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Eugene, Oregon, United States
Teva Investigational Site 13554
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Philadelphia, Pennsylvania, United States
Teva Investigational Site 13608
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Uniontown, Pennsylvania, United States
Teva Investigational Site 13556
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Mount Pleasant, South Carolina, United States
Teva Investigational Site 13551
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Memphis, Tennessee, United States
Teva Investigational Site 13560
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Bristol, Tennessee, United States
Teva Investigational Site 13623
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Dallas, Texas, United States
Teva Investigational Site 13611
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Plano, Texas, United States
Teva Investigational Site 13614
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Murray, Utah, United States
Teva Investigational Site 13630
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Virginia Beach, Virginia, United States
Teva Investigational Site 13600
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Morgantown, West Virginia, United States
Teva Investigational Site 11122
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Newmarket, Ontario, Canada
Teva Investigational Site 11124
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Hamilton, Ontario, Canada
Teva Investigational Site 11121
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Montreal, Canada
Teva Investigational Site 54145
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Pardubice, Czechia
Teva Investigational Site 54141
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Kunratice, Czechia
Teva Investigational Site 54142
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Prague 4, Czechia
Teva Investigational Site 54146
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Praha 3, Czechia
Teva Investigational Site 40018
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Helsinki, Finland
Teva Investigational Site 54143
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Praha, Czechia
Teva Investigational Site 40016
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Turku, Finland
Teva Investigational Site 40017
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Helsinki, Finland
Teva Investigational Site 80099
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Jerusalem, Israel
Teva Investigational Site 80096
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Holon, Israel
Teva Investigational Site 84070
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Saitama, Japan
Teva Investigational Site 13628
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Birmingham, Alabama, United States
Teva Investigational Site 13577
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Birmingham, Alabama, United States
Teva Investigational Site 13633
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Denver, Colorado, United States
Teva Investigational Site 13561
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Oklahoma City, Oklahoma, United States
Teva Investigational Site 13532
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Nashville, Tennessee, United States
Teva Investigational Site 13552
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Nashville, Tennessee, United States
Teva Investigational Site 11120
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Calgary, Canada
Teva Investigational Site 13606
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Phoenix, Arizona, United States
Teva Investigational Site 13550
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Stamford, Connecticut, United States
Teva Investigational Site 13579
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Phoenix, Arizona, United States
Teva Investigational Site 13568
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Encino, California, United States
Teva Investigational Site 13567
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Palm Beach Gardens, Florida, United States
Teva Investigational Site 13563
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East Hartford, Connecticut, United States
Teva Investigational Site 13598
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Wichita, Kansas, United States
Teva Investigational Site 13538
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Santa Monica, California, United States
Teva Investigational Site 13607
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Hialeah, Florida, United States
Teva Investigational Site 13585
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Chicago, Illinois, United States
Teva Investigational Site 13593
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Colorado Springs, Colorado, United States
Teva Investigational Site 13571
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Redondo Beach, California, United States
Teva Investigational Site 13602
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Little Rock, Arkansas, United States
Teva Investigational Site 13546
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Fullerton, California, United States
Teva Investigational Site 13536
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Springfield, Missouri, United States
Teva Investigational Site 13590
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Boston, Massachusetts, United States
Teva Investigational Site 13557
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Boulder, Colorado, United States
Teva Investigational Site 13616
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Pinellas Park, Florida, United States
Teva Investigational Site 13573
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San Diego, California, United States
Teva Investigational Site 13635
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Bradenton, Florida, United States
Teva Investigational Site 13559
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Jacksonville, Florida, United States
Teva Investigational Site 13604
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Boise, Idaho, United States
Teva Investigational Site 13617
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Wichita, Kansas, United States
Teva Investigational Site 13627
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Evanston, Illinois, United States
Teva Investigational Site 13544
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Greensboro, North Carolina, United States
Teva Investigational Site 13609
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Akron, Ohio, United States
Teva Investigational Site 13634
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Akron, Ohio, United States
Teva Investigational Site 13569
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Cleveland, Ohio, United States
Teva Investigational Site 13591
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Jenkintown, Pennsylvania, United States
Teva Investigational Site 13615
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Greer, South Carolina, United States
Teva Investigational Site 84072
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Chofu-shi, Japan
Teva Investigational Site 84068
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Shizuoka, Japan
Teva Investigational Site 50399
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Kazan, Russian Federation
Teva Investigational Site 84063
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Shinjuku-ku, Japan
Teva Investigational Site 84071
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Toyonaka, Japan
Teva Investigational Site 53364
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Krakow, Poland
Teva Investigational Site 53363
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Krakow, Poland
Teva Investigational Site 54144
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Brno, Czechia
Teva Investigational Site 11123
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Sarnia, Canada
Teva Investigational Site 31205
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Valladolid, Spain
Teva Investigational Site 80098
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Nahariya, Israel
Teva Investigational Site 50394
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Moscow, Russian Federation
Teva Investigational Site 80097
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Netanya, Israel
Teva Investigational Site 80100
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Ramat Gan, Israel
Teva Investigational Site 80095
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Tel Aviv, Israel
Teva Investigational Site 84073
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Kawasaki, Japan
Teva Investigational Site 84062
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Osaka-shi, Japan
Teva Investigational Site 84066
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Kagoshima-shi, Japan
Teva Investigational Site 84069
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Kai, Japan
Teva Investigational Site 53367
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Warsaw, Poland
Teva Investigational Site 50398
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Nizhniy Novgorod, Russian Federation
Teva Investigational Site 31206
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Zaragoza, Spain
Teva Investigational Site 31207
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Madrid, Spain
Teva Investigational Site 31208
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Pamplona, Spain
Teva Investigational Site 13581
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West Jordan, Utah, United States
Teva Investigational Site 13631
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Englewood, Colorado, United States
Teva Investigational Site 13540
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Long Beach, California, United States
Teva Investigational Site 13632
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Redlands, California, United States
Teva Investigational Site 13620
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Atlanta, Georgia, United States
Teva Investigational Site 13545
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Raleigh, North Carolina, United States
Teva Investigational Site 13587
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Orlando, Florida, United States
Teva Investigational Site 13629
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Aurora, Colorado, United States
Teva Investigational Site 13566
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Louisville, Kentucky, United States
Teva Investigational Site 13539
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Ann Arbor, Michigan, United States
Teva Investigational Site 13534
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Kansas City, Missouri, United States
Teva Investigational Site 13541
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Austin, Texas, United States
Teva Investigational Site 13597
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Gainesville, Florida, United States
Teva Investigational Site 13588
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Albuquerque, New Mexico, United States
Teva Investigational Site 13595
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Walnut Creek, California, United States