search
Back to results

Reducing Involuntary Movements in Participants With Tardive Dyskinesia (RIM-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 - undefined (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
  • Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia
  • Participants 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 participants must not be pregnant and agree to an acceptable method of contraception

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 (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) and received study drug 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 160
  • Teva Investigational Site 176
  • Teva Investigational Site 121
  • Teva Investigational Site 147
  • Teva Investigational Site 174
  • Teva Investigational Site 130
  • 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 154
  • Teva Investigational Site 101
  • 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 146
  • Teva Investigational Site 114
  • Teva Investigational Site 133
  • Teva Investigational Site 149
  • Teva Investigational Site 151
  • Teva Investigational Site 115
  • Teva Investigational Site 141
  • Teva Investigational Site 167
  • Teva Investigational Site 166
  • Teva Investigational Site 559
  • Teva Investigational Site 556
  • Teva Investigational Site 535
  • Teva Investigational Site 557
  • Teva Investigational Site 533
  • Teva Investigational Site 530
  • Teva Investigational Site 502
  • Teva Investigational Site 504
  • Teva Investigational Site 540
  • Teva Investigational Site 538
  • Teva Investigational Site 541
  • Teva Investigational Site 539
  • Teva Investigational Site 546
  • Teva Investigational Site 545
  • 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 524
  • Teva Investigational Site 549
  • Teva Investigational Site 522
  • Teva Investigational Site 550
  • 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

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

Part A: SD-809

Part B: Placebo

Part B: SD-809

Part C: SD-809

Arm Description

Participants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158.

Participants will receive placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter will receive SD-809 (stable dose) for 12 weeks.

Participants will receive SD-809 (stable dose) for 1 week in randomized withdrawal period and will continue to receive the same dose of SD-809 for an additional 12 weeks.

EU participants who complete Part B and willing to continue in the study will continue treatment with SD-809 for 52 weeks at the dose administered during the 12-week open-label period of Part B.

Outcomes

Primary Outcome Measures

Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal
AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: 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 treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

Secondary Outcome Measures

Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating
The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease.
Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC)
A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.
Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC)
A treatment success was defined as much or very much improved on the PGIC from baseline of this study. The PGIC is single-item questionnaire that asks the participant to assess their TD symptoms at specific visits/weeks after initiating therapy. The PGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.
Part A: Change From Baseline in Modified CDQ-24 Score at Week 158
The CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants 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 were 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 participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment.

Full Information

First Posted
July 22, 2014
Last Updated
March 31, 2022
Sponsor
Auspex Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02198794
Brief Title
Reducing Involuntary Movements in Participants With Tardive Dyskinesia
Acronym
RIM-TD
Official Title
An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2014 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
December 14, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.
Detailed Description
Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: SD-809
Arm Type
Experimental
Arm Description
Participants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158.
Arm Title
Part B: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter will receive SD-809 (stable dose) for 12 weeks.
Arm Title
Part B: SD-809
Arm Type
Active Comparator
Arm Description
Participants will receive SD-809 (stable dose) for 1 week in randomized withdrawal period and will continue to receive the same dose of SD-809 for an additional 12 weeks.
Arm Title
Part C: SD-809
Arm Type
Experimental
Arm Description
EU participants who complete Part B and willing to continue in the study will continue treatment with SD-809 for 52 weeks at the dose administered during the 12-week open-label period of Part B.
Intervention Type
Drug
Intervention Name(s)
SD-809
Other Intervention Name(s)
Deutetrabenazine; TEV-50717
Intervention Description
SD-809 will be administered per dose and schedule specified in the arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to SD-809 will be administered per schedule specified in the arm.
Primary Outcome Measure Information:
Title
Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal
Description
AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: 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 treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame
Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)
Title
Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Time Frame
Day 1 of Part B, Day 7 of Part B
Secondary Outcome Measure Information:
Title
Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Time Frame
Baseline, Week 145
Title
Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Time Frame
Baseline, Week 158
Title
Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Time Frame
Baseline, Week 145
Title
Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Time Frame
Baseline, Week 158
Title
Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Time Frame
Baseline to Week 145
Title
Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.
Time Frame
Baseline to Week 145
Title
Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating
Description
The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease.
Time Frame
Baseline, Week 145
Title
Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC)
Description
A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.
Time Frame
Baseline up to Week 145
Title
Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC)
Description
A treatment success was defined as much or very much improved on the PGIC from baseline of this study. The PGIC is single-item questionnaire that asks the participant to assess their TD symptoms at specific visits/weeks after initiating therapy. The PGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.
Time Frame
Baseline up to Week 145
Title
Part A: Change From Baseline in Modified CDQ-24 Score at Week 158
Description
The CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants 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 were 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 participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment.
Time Frame
Baseline, Week 158

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia Participants 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 participants must not be pregnant and agree to an acceptable method of contraception 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 (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) and received study drug 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, M.D.
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 160
City
Irvine
State/Province
California
ZIP/Postal Code
92614
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 130
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 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 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 146
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Teva Investigational Site 114
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
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 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
ZIP/Postal Code
999999
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 533
City
Prague 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Teva Investigational Site 530
City
Prague 6
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Teva Investigational Site 502
City
Gera
ZIP/Postal Code
07551
Country
Germany
Facility Name
Teva Investigational Site 504
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Teva Investigational Site 540
City
Balassagyarmat
ZIP/Postal Code
999999
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 539
City
Doba
ZIP/Postal Code
8482
Country
Hungary
Facility Name
Teva Investigational Site 546
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Teva Investigational Site 545
City
Kalocsa
ZIP/Postal Code
6300
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 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 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 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

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)
Citations:
PubMed Identifier
31296586
Citation
Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323. doi: 10.1136/jnnp-2018-319918. Epub 2019 Jul 10.
Results Reference
derived

Learn more about this trial

Reducing Involuntary Movements in Participants With Tardive Dyskinesia

We'll reach out to this number within 24 hrs