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Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD)

Primary Purpose

Tardive Dyskinesia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SD-809
Placebo
Sponsored by
Auspex Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tardive Dyskinesia focused on measuring Dyskinesias, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Signs and Symptoms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of using a dopamine receptor antagonist for at least 3 months
  • Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
  • Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
  • Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
  • History of being compliant with prescribed medications
  • Able to swallow study drug whole
  • Be in good general health and is expected to attend all study visits and complete study assessments
  • Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study

Exclusion Criteria:

  • Currently receiving medication for the treatment of tardive dyskinesia
  • Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
  • Have a serious untreated or undertreated psychiatric illness
  • Have recent history or presence of violent behavior
  • Have unstable or serious medical illness
  • Have evidence of hepatic impairment
  • Have evidence of renal impairment
  • Have known allergy to any component of SD-809 or tetrabenazine
  • Has participated in an investigational drug or device trial and received study drug or device within 30 days
  • Have acknowledged use of illicit drugs
  • Have a history of alcohol or substance abuse in the previous 12 months

Sites / Locations

  • Teva Investigational Site 145
  • Teva Investigational Site 107
  • Teva Investigational Site 108
  • Teva Investigational Site 123
  • Teva Investigational Site 177
  • Teva Investigational Site 160
  • Teva Investigational Site 106
  • Teva Investigational Site 176
  • Teva Investigational Site 121
  • Teva Investigational Site 147
  • Teva Investigational Site 174
  • Teva Investigational Site 170
  • Teva Investigational Site 102
  • Teva Investigational Site 104
  • Teva Investigational Site 110
  • Teva Investigational Site 169
  • Teva Investigational Site 129
  • Teva Investigational Site 139
  • Teva Investigational Site 156
  • Teva Investigational Site 157
  • Teva Investigational Site 117
  • Teva Investigational Site 150
  • Teva Investigational Site 153
  • Teva Investigational Site 162
  • Teva Investigational Site 112
  • Teva Investigational Site 144
  • Teva Investigational Site 155
  • Teva Investigational Site 165
  • Teva Investigational Site 131
  • Teva Investigational Site 113
  • Teva Investigational Site 164
  • Teva Investigational Site 154
  • Teva Investigational Site 101
  • Teva Investigational Site 135
  • Teva Investigational Site 118
  • Teva Investigational Site 142
  • Teva Investigational Site 175
  • Teva Investigational Site 161
  • Teva Investigational Site 178
  • Teva Investigational Site 128
  • Teva Investigational Site 172
  • Teva Investigational Site 148
  • Teva Investigational Site 138
  • Teva Investigational Site 146
  • Teva Investigational Site 133
  • Teva Investigational Site 149
  • Teva Investigational Site 151
  • Teva Investigational Site 115
  • Teva Investigational Site 141
  • Teva Investigational Site 168
  • Teva Investigational Site 171
  • Teva Investigational Site 167
  • Teva Investigational Site 166
  • Teva Investigational Site 559
  • Teva Investigational Site 556
  • Teva Investigational Site 558
  • Teva Investigational Site 535
  • Teva Investigational Site 557
  • Teva Investigational Site 530
  • Teva Investigational Site 531
  • Teva Investigational Site 533
  • Teva Investigational Site 532
  • Teva Investigational Site 534
  • Teva Investigational Site 502
  • Teva Investigational Site 503
  • Teva Investigational Site 504
  • Teva Investigational Site 507
  • Teva Investigational Site 544
  • Teva Investigational Site 501
  • Teva Investigational Site 540
  • Teva Investigational Site 538
  • Teva Investigational Site 541
  • Teva Investigational Site 537
  • Teva Investigational Site 542
  • Teva Investigational Site 539
  • Teva Investigational Site 546
  • Teva Investigational Site 545
  • Teva Investigational Site 547
  • Teva Investigational Site 514
  • Teva Investigational Site 554
  • Teva Investigational Site 510
  • Teva Investigational Site 519
  • Teva Investigational Site 536
  • Teva Investigational Site 523
  • Teva Investigational Site 517
  • Teva Investigational Site 513
  • Teva Investigational Site 512
  • Teva Investigational Site 552
  • Teva Investigational Site 520
  • Teva Investigational Site 509
  • Teva Investigational Site 508
  • Teva Investigational Site 511
  • Teva Investigational Site 515
  • Teva Investigational Site 524
  • Teva Investigational Site 549
  • Teva Investigational Site 521
  • Teva Investigational Site 518
  • Teva Investigational Site 522
  • Teva Investigational Site 550
  • Teva Investigational Site 555
  • Teva Investigational Site 516
  • Teva Investigational Site 529
  • Teva Investigational Site 525
  • Teva Investigational Site 527
  • Teva Investigational Site 528
  • Teva Investigational Site 526

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

SD-809 12 mg/day

SD-809 24 mg/day

SD-809 36 mg/day

Arm Description

Placebo tablets taken twice daily for 12 weeks.

SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.

Outcomes

Primary Outcome Measures

Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)
AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.

Secondary Outcome Measures

Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)
The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% confidence interval (CI) was calculated with the Wilson (score) confidence limits.
Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12
The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains are evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 - 96. Negative change from baseline scores indicate improvement. For patients with missing data at week 12, the baseline or last available value was used as the week 12 value.
Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)
The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% CI was calculated with the Wilson (score) confidence limits.
Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12
Responders who had a 50% or greater improvement in total motor modified AIMS at Week 12 as compared to baseline were reported as a percentage of participants with an outcome at Week 12. The responder 95% CI is calculated with the Wilson (score) confidence limits. AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.
Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)
AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.
Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points
AIMS is an assessment tool used to detect and follow the severity of TD over time, composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. Participants with missing data are classified as non-responders. The responder 95% CI is calculated with the Wilson (score) confidence limits. If any of the expected cell counts are < 5, exact Clopper Pearson limits are presented. Data report the percentage of participants who responded to the percentage improvement indicated in each row.
Participants With Adverse Events During the Overall Treatment Period
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

Full Information

First Posted
November 12, 2014
Last Updated
November 5, 2021
Sponsor
Auspex Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02291861
Brief Title
Addressing Involuntary Movements in Tardive Dyskinesia
Acronym
AIM-TD
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 31, 2014 (Actual)
Primary Completion Date
August 19, 2016 (Actual)
Study Completion Date
August 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auspex Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia
Keywords
Dyskinesias, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Signs and Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets taken twice daily for 12 weeks.
Arm Title
SD-809 12 mg/day
Arm Type
Experimental
Arm Description
SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
Arm Title
SD-809 24 mg/day
Arm Type
Experimental
Arm Description
SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
Arm Title
SD-809 36 mg/day
Arm Type
Experimental
Arm Description
SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
Intervention Type
Drug
Intervention Name(s)
SD-809
Other Intervention Name(s)
deutetrabenzine, Austedo
Intervention Description
SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.
Primary Outcome Measure Information:
Title
Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)
Description
AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.
Time Frame
Day 0 (Baseline), Weeks 2, 4, 8 and 12
Secondary Outcome Measure Information:
Title
Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)
Description
The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% confidence interval (CI) was calculated with the Wilson (score) confidence limits.
Time Frame
Week 12
Title
Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12
Description
The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains are evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 - 96. Negative change from baseline scores indicate improvement. For patients with missing data at week 12, the baseline or last available value was used as the week 12 value.
Time Frame
Day 0 (Baseline), Week 12
Title
Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)
Description
The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% CI was calculated with the Wilson (score) confidence limits.
Time Frame
Week 12
Title
Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12
Description
Responders who had a 50% or greater improvement in total motor modified AIMS at Week 12 as compared to baseline were reported as a percentage of participants with an outcome at Week 12. The responder 95% CI is calculated with the Wilson (score) confidence limits. AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.
Time Frame
Day 0 (Baseline), Week 12
Title
Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)
Description
AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.
Time Frame
Day 0 (Baseline), Weeks 2, 4, 8 and 12
Title
Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points
Description
AIMS is an assessment tool used to detect and follow the severity of TD over time, composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. Participants with missing data are classified as non-responders. The responder 95% CI is calculated with the Wilson (score) confidence limits. If any of the expected cell counts are < 5, exact Clopper Pearson limits are presented. Data report the percentage of participants who responded to the percentage improvement indicated in each row.
Time Frame
Day 0 (Baseline), Week 12
Title
Participants With Adverse Events During the Overall Treatment Period
Description
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame
Day 1 to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of using a dopamine receptor antagonist for at least 3 months Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months History of being compliant with prescribed medications Able to swallow study drug whole Be in good general health and is expected to attend all study visits and complete study assessments Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study Exclusion Criteria: Currently receiving medication for the treatment of tardive dyskinesia Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias Have a serious untreated or undertreated psychiatric illness Have recent history or presence of violent behavior Have unstable or serious medical illness Have evidence of hepatic impairment Have evidence of renal impairment Have known allergy to any component of SD-809 or tetrabenazine Has participated in an investigational drug or device trial and received study drug or device within 30 days Have acknowledged use of illicit drugs Have a history of alcohol or substance abuse in the previous 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 145
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Teva Investigational Site 107
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Teva Investigational Site 108
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Teva Investigational Site 123
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Teva Investigational Site 177
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Teva Investigational Site 160
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Teva Investigational Site 106
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Teva Investigational Site 176
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Teva Investigational Site 121
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Teva Investigational Site 147
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1769
Country
United States
Facility Name
Teva Investigational Site 174
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Teva Investigational Site 170
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Teva Investigational Site 102
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Teva Investigational Site 104
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
Teva Investigational Site 110
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Teva Investigational Site 169
City
San Rafael
State/Province
California
ZIP/Postal Code
94901
Country
United States
Facility Name
Teva Investigational Site 129
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Teva Investigational Site 139
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Teva Investigational Site 156
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Teva Investigational Site 157
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Teva Investigational Site 117
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Teva Investigational Site 150
City
Lake City
State/Province
Florida
ZIP/Postal Code
32025
Country
United States
Facility Name
Teva Investigational Site 153
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Teva Investigational Site 162
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Teva Investigational Site 112
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Teva Investigational Site 144
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Teva Investigational Site 155
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Teva Investigational Site 165
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Teva Investigational Site 131
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Teva Investigational Site 113
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Teva Investigational Site 164
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Teva Investigational Site 154
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Teva Investigational Site 101
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Teva Investigational Site 135
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Teva Investigational Site 118
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Teva Investigational Site 142
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Teva Investigational Site 175
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Teva Investigational Site 161
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Teva Investigational Site 178
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526-9467
Country
United States
Facility Name
Teva Investigational Site 128
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Teva Investigational Site 172
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Teva Investigational Site 148
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Teva Investigational Site 138
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
Teva Investigational Site 146
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 133
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Teva Investigational Site 149
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Teva Investigational Site 151
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Teva Investigational Site 115
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Facility Name
Teva Investigational Site 141
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Teva Investigational Site 168
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Teva Investigational Site 171
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Teva Investigational Site 167
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Teva Investigational Site 166
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Teva Investigational Site 559
City
Havirov
ZIP/Postal Code
736 01
Country
Czechia
Facility Name
Teva Investigational Site 556
City
Hostivice
Country
Czechia
Facility Name
Teva Investigational Site 558
City
Hradec Kralove
ZIP/Postal Code
503 41
Country
Czechia
Facility Name
Teva Investigational Site 535
City
Litomerice
ZIP/Postal Code
412 01
Country
Czechia
Facility Name
Teva Investigational Site 557
City
Plzen
ZIP/Postal Code
312 00
Country
Czechia
Facility Name
Teva Investigational Site 530
City
Prague 6
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Teva Investigational Site 531
City
Prague 8
ZIP/Postal Code
181 02
Country
Czechia
Facility Name
Teva Investigational Site 533
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Teva Investigational Site 532
City
Praha 5
ZIP/Postal Code
158 00
Country
Czechia
Facility Name
Teva Investigational Site 534
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Teva Investigational Site 502
City
Gera
ZIP/Postal Code
07551
Country
Germany
Facility Name
Teva Investigational Site 503
City
Haag In Oberbayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
Teva Investigational Site 504
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Teva Investigational Site 507
City
Prien am Chiemsee
ZIP/Postal Code
83209
Country
Germany
Facility Name
Teva Investigational Site 544
City
Taufkirchen
ZIP/Postal Code
84416
Country
Germany
Facility Name
Teva Investigational Site 501
City
Wolfach
ZIP/Postal Code
77709
Country
Germany
Facility Name
Teva Investigational Site 540
City
Balassagyarmat
Country
Hungary
Facility Name
Teva Investigational Site 538
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Teva Investigational Site 541
City
Budapest
ZIP/Postal Code
1148
Country
Hungary
Facility Name
Teva Investigational Site 537
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Teva Investigational Site 542
City
Budapest
ZIP/Postal Code
H-1135
Country
Hungary
Facility Name
Teva Investigational Site 539
City
Doba
ZIP/Postal Code
8482
Country
Hungary
Facility Name
Teva Investigational Site 546
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Teva Investigational Site 545
City
Kalocsa
ZIP/Postal Code
6300
Country
Hungary
Facility Name
Teva Investigational Site 547
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Teva Investigational Site 514
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Facility Name
Teva Investigational Site 554
City
Bialystok
ZIP/Postal Code
15-756
Country
Poland
Facility Name
Teva Investigational Site 510
City
Bydgoszcz
ZIP/Postal Code
85-015
Country
Poland
Facility Name
Teva Investigational Site 519
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Facility Name
Teva Investigational Site 536
City
Bydgoszcz
ZIP/Postal Code
85-156
Country
Poland
Facility Name
Teva Investigational Site 523
City
Chelmno
ZIP/Postal Code
86-200
Country
Poland
Facility Name
Teva Investigational Site 517
City
Choroszcz
ZIP/Postal Code
16-070
Country
Poland
Facility Name
Teva Investigational Site 513
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Teva Investigational Site 512
City
Katowice
ZIP/Postal Code
40-097
Country
Poland
Facility Name
Teva Investigational Site 552
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Teva Investigational Site 520
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Teva Investigational Site 509
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Teva Investigational Site 508
City
Lodz
ZIP/Postal Code
90-130
Country
Poland
Facility Name
Teva Investigational Site 511
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Teva Investigational Site 515
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Teva Investigational Site 524
City
Lublin
ZIP/Postal Code
20-831
Country
Poland
Facility Name
Teva Investigational Site 549
City
Olsztyn
ZIP/Postal Code
10-443
Country
Poland
Facility Name
Teva Investigational Site 521
City
Pruszkow
ZIP/Postal Code
05-802
Country
Poland
Facility Name
Teva Investigational Site 518
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Teva Investigational Site 522
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Teva Investigational Site 550
City
Warszawa
ZIP/Postal Code
00-465
Country
Poland
Facility Name
Teva Investigational Site 555
City
Warszawa
ZIP/Postal Code
00-669
Country
Poland
Facility Name
Teva Investigational Site 516
City
Wroclaw
ZIP/Postal Code
50-227
Country
Poland
Facility Name
Teva Investigational Site 529
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Teva Investigational Site 525
City
Hronovce
ZIP/Postal Code
935 61
Country
Slovakia
Facility Name
Teva Investigational Site 527
City
Kosice
ZIP/Postal Code
04017
Country
Slovakia
Facility Name
Teva Investigational Site 528
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
Teva Investigational Site 526
City
Roznava
ZIP/Postal Code
04801
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
28668671
Citation
Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojarvi J, Jarskog LF, Jimenez-Shahed J, Kumar R, McEvoy JP, Ochudlo S, Ondo WG, Fernandez HH. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017 Aug;4(8):595-604. doi: 10.1016/S2215-0366(17)30236-5. Epub 2017 Jun 28.
Results Reference
result

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Addressing Involuntary Movements in Tardive Dyskinesia

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