Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
- Registration Number
- NCT01305408
- Lead Sponsor
- Cephalon
- Brief Summary
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
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The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
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Documentation that the patient has had at least 1 previous manic or mixed episode.
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The patient has had no more than 6 mood episodes in the last year.
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The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
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The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
- The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
- The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
- The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
- The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
- The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
- The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.
- The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
- The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
- The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
- The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks. Armodafinil 150 mg/day Armodafinil Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) Day 0 (baseline), Week 8 The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
- Secondary Outcome Measures
Name Time Method Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks) The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16) Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score Day 0 (baseline), last postbaseline observation (up to 8 weeks) The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
Participants With Treatment-Emergent Adverse Events (TEAE) Day 1 to Week 9 AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.
Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score Day 0 (baseline), last postbaseline observation (up to 8 weeks) HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score Day 0 (baseline), last postbaseline observation (up to 8 weeks) The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.
Trial Locations
- Locations (130)
Teva Investigational Site 225
🇺🇸Birmingham, Alabama, United States
Teva Investigational Site 295
🇺🇸Sherman Oaks, California, United States
Teva Investigational Site 122
🇺🇸Temecula, California, United States
Teva Investigational Site 606
🇺🇸Jacksonville Beach, Florida, United States
Teva Investigational Site 127
🇺🇸Lauderhill, Florida, United States
Teva Investigational Site 608
🇺🇸Tampa, Florida, United States
Teva Investigational Site 116
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 205
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 600
🇺🇸Lafayette, Indiana, United States
Teva Investigational Site 195
🇺🇸Park Ridge, Illinois, United States
Teva Investigational Site 611
🇺🇸Indianapolis, Indiana, United States
Teva Investigational Site 207
🇺🇸Brooklyn, New York, United States
Teva Investigational Site 202
🇺🇸New York, New York, United States
Teva Investigational Site 614
🇺🇸Wilmington, North Carolina, United States
Teva Investigational Site 110
🇺🇸Staten Island, New York, United States
Teva Investigational Site 411
🇺🇸Staten Island, New York, United States
Teva Investigational Site 610
🇺🇸Cincinnati, Ohio, United States
Teva Investigational Site 615
🇺🇸Toledo, Ohio, United States
Teva Investigational Site 401
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 609
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 616
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 403
🇺🇸Desoto, Texas, United States
Teva Investigational Site 406
🇺🇸Allentown, Pennsylvania, United States
Teva Investigational Site 605
🇺🇸Spokane, Washington, United States
Teva Investigational Site 613
🇺🇸Kirkland, Washington, United States
Teva Investigational Site 612
🇺🇸Friendswood, Texas, United States
Teva Investigational Site 408
🇺🇸Salt Lake City, Utah, United States
Teva Investigational Site 884
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 236
🇦🇷Córdoba, Argentina
Teva Investigational Site 886
🇦🇷La Plata, Argentina
Teva Investigational Site 623
🇧🇷Belo Horizonte, Brazil
Teva Investigational Site 626
🇧🇷Curitiba-Parana, Brazil
Teva Investigational Site 621
🇧🇷Distrito de Rubiao Junior, Brazil
Teva Investigational Site 624
🇧🇷Rio de Janeiro, Brazil
Teva Investigational Site 622
🇧🇷Salvador, Brazil
Teva Investigational Site 628
🇧🇷Sao Paolo, Brazil
Teva Investigational Site 146
🇧🇬Kardzhali, Bulgaria
Teva Investigational Site 148
🇧🇬Kazanlak, Bulgaria
Teva Investigational Site 145
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 147
🇧🇬Sofia, Bulgaria
Teva Investigational Site 854
🇧🇬Sofia, Bulgaria
Teva Investigational Site 855
🇧🇬Sofia, Bulgaria
Teva Investigational Site 635
🇭🇷Rijeka, Croatia
Teva Investigational Site 631
🇭🇷Split, Croatia
Teva Investigational Site 632
🇭🇷Zagreb, Croatia
Teva Investigational Site 633
🇭🇷Zagreb, Croatia
Teva Investigational Site 634
🇭🇷Zagreb, Croatia
Teva Investigational Site 717
🇫🇮Helsinki, Finland
Teva Investigational Site 716
🇫🇮Helsinki, Finland
Teva Investigational Site 718
🇫🇮Turku, Finland
Teva Investigational Site 655
🇩🇪Achim, Germany
Teva Investigational Site 652
🇩🇪Mittweida, Germany
Teva Investigational Site 719
🇫🇮Kangasala, Finland
Teva Investigational Site 656
🇩🇪Berlin, Germany
Teva Investigational Site 662
🇭🇺Budapest, Hungary
Teva Investigational Site 651
🇩🇪Dresden, Germany
Teva Investigational Site 653
🇩🇪Cologne, Germany
Teva Investigational Site 654
🇩🇪Freiburg, Germany
Teva Investigational Site 689
🇮🇹Firenze, Italy
Teva Investigational Site 688
🇮🇹Catania, Italy
Teva Investigational Site 686
🇮🇹Genova, Italy
Teva Investigational Site 691
🇮🇹Lido di Camaiore(LU), Italy
Teva Investigational Site 690
🇮🇹Naples, Italy
Teva Investigational Site 692
🇮🇹Roma, Italy
Teva Investigational Site 259
🇵🇱Bialystok, Poland
Teva Investigational Site 155
🇵🇱Krakow, Poland
Teva Investigational Site 255
🇵🇱Skorzewo, Poland
Teva Investigational Site 157
🇵🇱Tuszyn, Poland
Teva Investigational Site 177
🇷🇸Belgrade, Serbia
Teva Investigational Site 831
🇷🇸Belgrade, Serbia
Teva Investigational Site 835
🇷🇸Belgrade, Serbia
Teva Investigational Site 832
🇷🇸Belgrade, Serbia
Teva Investigational Site 837
🇷🇸Nis, Serbia
Teva Investigational Site 176
🇷🇸Kragujevac, Serbia
Teva Investigational Site 700
🇸🇰Bojnice, Slovakia
Teva Investigational Site 696
🇸🇰Roznava, Slovakia
Teva Investigational Site 707
🇿🇦Cape Town, South Africa
Teva Investigational Site 709
🇿🇦Cape Town, South Africa
Teva Investigational Site 712
🇿🇦Cape Town, South Africa
Teva Investigational Site 708
🇿🇦Centurion, South Africa
Teva Investigational Site 710
🇿🇦Johannesburg, South Africa
Teva Investigational Site 711
🇿🇦Paarl, South Africa
Teva Investigational Site 706
🇿🇦Pretoria, South Africa
Teva Investigational Site 180
🇺🇦Lugansk, Ukraine
Teva Investigational Site 281
🇺🇦Kiev, Ukraine
Teva Investigational Site 875
🇺🇦Odessa, Ukraine
Teva Investigational Site 183
🇺🇦Poltava, Ukraine
Teva Investigational Site 871
🇺🇦s. Oleksandrivka, Ukraine
Teva Investigational Site 134
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 136
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 881
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 888
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 603
🇺🇸Watertown, Massachusetts, United States
Teva Investigational Site 138
🇦🇷La Plata, Buenos Aires, Argentina
Teva Investigational Site 371
🇦🇷La Plata, Argentina
Teva Investigational Site 882
🇦🇷Mendoza, Argentina
Teva Investigational Site 883
🇦🇷Mendoza, Argentina
Teva Investigational Site 885
🇦🇷Mendoza, Argentina
Teva Investigational Site 887
🇦🇷Mendoza, Argentina
Teva Investigational Site 238
🇦🇷Rosario, Argentina
Teva Investigational Site 248
🇧🇬Bourgas, Bulgaria
Teva Investigational Site 853
🇧🇬Pazardjik, Bulgaria
Teva Investigational Site 852
🇧🇬Pleven, Bulgaria
Teva Investigational Site 370
🇧🇬Ruse, Bulgaria
Teva Investigational Site 149
🇧🇬Sofia, Bulgaria
Teva Investigational Site 245
🇧🇬Varna, Bulgaria
Teva Investigational Site 244
🇧🇬Sofia, Bulgaria
Teva Investigational Site 247
🇧🇬Sofia, Bulgaria
Teva Investigational Site 851
🇧🇬Varna, Bulgaria
Teva Investigational Site 856
🇧🇬Varna, Bulgaria
Teva Investigational Site 665
🇭🇺Gyor, Hungary
Teva Investigational Site 666
🇭🇺Nagykallo, Hungary
Teva Investigational Site 661
🇭🇺Budapest, Hungary
Teva Investigational Site 257
🇵🇱Gdansk, Poland
Teva Investigational Site 258
🇵🇱Gdynia, Poland
Teva Investigational Site 861
🇵🇱Szczecin, Poland
Teva Investigational Site 834
🇷🇸Novi Knezevac, Serbia
Teva Investigational Site 699
🇸🇰Bratislava, Slovakia
Teva Investigational Site 697
🇸🇰Rimavska Sobota, Slovakia
Teva Investigational Site 698
🇸🇰Trencin, Slovakia
Teva Investigational Site 181
🇺🇦Dnipropetrovsk, Ukraine
Teva Investigational Site 872
🇺🇦Donetsk, Ukraine
Teva Investigational Site 282
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 873
🇺🇦Lviv, Ukraine
Teva Investigational Site 182
🇺🇦Vinnytsya, Ukraine
Teva Investigational Site 135
🇦🇷Córdoba Capital, Argentina
Teva Investigational Site 687
🇮🇹Pisa, Italy
Teva Investigational Site 693
🇮🇹Pisa, Italy
Teva Investigational Site 627
🇧🇷Itapira -Sao Paulo, Brazil
Teva Investigational Site 664
🇭🇺Budapest, Hungary