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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

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

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

Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating

Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating

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

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

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

NCT ID

NCT02198794

First Posted

July 22, 2014

Last Updated

March 31, 2022

Sponsor

Auspex Pharmaceuticals, Inc.

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

Data Monitoring Committee

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

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

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

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

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

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

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

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

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

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

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

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

Time Frame

Baseline up to Week 145

Title

Part A: Change From Baseline in Modified CDQ-24 Score at Week 158

Description

Time Frame

Baseline, Week 158

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

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Reducing Involuntary Movements in Participants With Tardive Dyskinesia

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Reducing Involuntary Movements in Participants With Tardive Dyskinesia (RIM-TD)

Tardive Dyskinesia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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