Back to results

Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents (ARTISTS)

Primary Purpose

Tourette Syndrome

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

TEV-50717

Placebo

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring adolescents, children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is younger than 18 years of age on day 1
Patient weighs at least 44 pounds (20 kg)
The patient's active tics are causing distress or impairment
Patient is able to swallow study medication whole
Patient is in good general health
Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study -- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Patient is 18 years of age or older.
Patient has a neurologic disorder other than TS that could obscure the evaluation of tics.
The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
Patient has clinically significant depression at screening or day 1. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.
Patient has a history of suicidal intent or related behaviors within 2 years of screening
Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
Patient has a first-degree relative who has completed suicide.
Patient has clinically significant obsessive-compulsive disorder (OCD) on day 1 that, in the opinion of the investigator, is the primary cause of impairment.
Patient has received comprehensive behavioral intervention for tics for TS or cognitive behavioral therapy for OCD within 4 weeks of screening.
Patient has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for reduction of tics within 4 weeks of the screening visit.
Patient has an unstable or serious medical illness at screening or day 1
Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
Patient has received a monoamine oxidase inhibitor within 14 days of the day 1 visit.
Patient has participated in an investigational drug or device study (with the exception of Study SD-809-C-17, Study TV50717-CNS-30046, or Study TV50717-CNS-30060) and received IMP/intervention within 30 days or 5 drug half-lives of day 1, whichever is longer.
The patient is a pregnant or lactating female, or plans to become pregnant during the study.
Patient has a history of, or acknowledges, alcohol-related disorder in the previous 12 months -- Additional criteria apply, please contact the investigator for more information

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

TEV-50717- Part A

TEV-50717- Part B RW

Placebo- Part B RW

Arm Description

All patients will undergo TEV-50717 dose titration in this study. Patients will receive 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose will be determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study.

TEV-50717 is administered during Part B Randomized Drug Withdrawal (RW) 2-week period.

Placebo is administered during Part B Randomized Drug Withdrawal (RW) 2-week period only.

Outcomes

Primary Outcome Measures

Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined

Adverse events were analyzed for all participants in Parts A & B combined as one group for this outcome measure. An AE 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. Incudes clinically significant changes such as changes in vital signs or lab values. Relationship of AE to treatment was determined by the Investigator. Serious AEs 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 participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II)

Adverse events were analyzed for Part B for this outcome measure. An AE 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. Incudes clinically significant changes such as changes in vital signs or lab values. Relationship of AE to treatment was determined by the Investigator. Serious AEs 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 participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score

Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time." It contains 2 subscales (emotional problems and functional problem). Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.

Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score

CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills. Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks. It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems). Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children.

Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30

Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30

Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)

C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide. Number of participants with any suicidal ideation or suicidal behavior are reported. Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.

Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) at Randomized Withdrawal Baseline Visit (Week 28) and Week 30

Secondary Outcome Measures

Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)

YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.

Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score

The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics). Lower scores indicate better quality of life. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.

Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score

The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?). The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.

Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score

C&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms. C&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem. Following 3 questions from 27-item questionnaire were assessed in ADL C&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?). Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem). Lower score indicated better quality of life. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.

Change From Randomized Withdrawal Baseline (Week 28) in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) to Week 30

YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. The model is an ANCOVA model that includes fixed effects for treatment group. The randomized withdrawal baseline TTS and age group at baseline (2 levels: 6-11 years, 12-18 years) are included as covariates.

Full Information

NCT ID

NCT03567291

First Posted

June 12, 2018

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

Nuvelution TS Pharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03567291

Brief Title

Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

Acronym

ARTISTS

Official Title

An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

The parent trials did not meet the primary endpoints of reduction in motor and phonic tics.

Study Start Date

May 25, 2018 (Actual)

Primary Completion Date

May 15, 2020 (Actual)

Study Completion Date

May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

Nuvelution TS Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.

Detailed Description

This is an otherwise open-label, single-arm study (Part A) that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period (Part B) followed by a 3 week blinded maintenance or re-titration (Part A resumed), and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies (SD-809-C-17 [Phase 1b], TV50717-CNS 30046 [Phase 2/3], or TV50717-CNS 30060 [Phase 3]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tourette Syndrome

Keywords

adolescents, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TEV-50717- Part A

Arm Type

Experimental

Arm Description

Arm Title

TEV-50717- Part B RW

Arm Type

Experimental

Arm Description

TEV-50717 is administered during Part B Randomized Drug Withdrawal (RW) 2-week period.

Arm Title

Placebo- Part B RW

Arm Type

Placebo Comparator

Arm Description

Placebo is administered during Part B Randomized Drug Withdrawal (RW) 2-week period only.

Intervention Type

Drug

Intervention Name(s)

TEV-50717

Other Intervention Name(s)

deutetrabenazine, SD-809

Intervention Description

6, 9, and 12 mg oral tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo comparator

Primary Outcome Measure Information:

Title

Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined

Description

Time Frame

Day 1 to Week 55

Title

Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II)

Description

Time Frame

Weeks 28 to 30

Title

Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score

Description

Time Frame

Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55

Title

Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score

Description

Time Frame

Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55

Title

Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30

Description

Time Frame

Week 28, Week 30

Title

Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30

Description

Time Frame

Week 28, Week 30

Title

Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55

Title

Description

Time Frame

Week 28, Week 30

Secondary Outcome Measure Information:

Title

Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)

Description

Time Frame

Baseline, Weeks 8, 15, 28, 41, 54, and 55

Title

Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score

Description

Time Frame

Baseline, Weeks 8, 15, 28, 41, 54, and 55

Title

Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score

Description

Time Frame

Baseline, Weeks 8, 15, 28, 41, 54, and 55

Title

Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score

Description

Time Frame

Baseline, Weeks 6, 28, 34, 54

Title

Change From Randomized Withdrawal Baseline (Week 28) in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) to Week 30

Description

YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. The model is an ANCOVA model that includes fixed effects for treatment group. The randomized withdrawal baseline TTS and age group at baseline (2 levels: 6-11 years, 12-18 years) are included as covariates.

Time Frame

Week 28, Week 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is younger than 18 years of age on day 1 Patient weighs at least 44 pounds (20 kg) The patient's active tics are causing distress or impairment Patient is able to swallow study medication whole Patient is in good general health Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study -- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: Patient is 18 years of age or older. Patient has a neurologic disorder other than TS that could obscure the evaluation of tics. The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder. Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder. Patient has clinically significant depression at screening or day 1. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening. Patient has a history of suicidal intent or related behaviors within 2 years of screening Patient has a history of a previous actual, interrupted, or aborted suicide attempt. Patient has a first-degree relative who has completed suicide. Patient has clinically significant obsessive-compulsive disorder (OCD) on day 1 that, in the opinion of the investigator, is the primary cause of impairment. Patient has received comprehensive behavioral intervention for tics for TS or cognitive behavioral therapy for OCD within 4 weeks of screening. Patient has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for reduction of tics within 4 weeks of the screening visit. Patient has an unstable or serious medical illness at screening or day 1 Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure. Patient has received a monoamine oxidase inhibitor within 14 days of the day 1 visit. Patient has participated in an investigational drug or device study (with the exception of Study SD-809-C-17, Study TV50717-CNS-30046, or Study TV50717-CNS-30060) and received IMP/intervention within 30 days or 5 drug half-lives of day 1, whichever is longer. The patient is a pregnant or lactating female, or plans to become pregnant during the study. Patient has a history of, or acknowledges, alcohol-related disorder in the previous 12 months -- Additional criteria apply, please contact the investigator for more information

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 046-0104

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Teva Investigational Site 046-0107

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Teva Investigational Site 046-0126

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Teva Investigational Site 046-0101

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

Facility Name

Teva Investigational Site 046-0111

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Teva Investigational Site 060-0160

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Teva Investigational Site 060-0166

City

Gulf Breeze

State/Province

Florida

ZIP/Postal Code

32561-4458

Country

United States

Facility Name

Teva Investigational Site 060-0161

City

Miami

State/Province

Florida

ZIP/Postal Code

33136-2107

Country

United States

Facility Name

Teva Investigational Site 046-0115

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Teva Investigational Site 060-0153

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Teva Investigational Site 046-0114

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

Teva Investigational Site 046-0116

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Teva Investigational Site 060-0155

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Teva Investigational Site 060-0164

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60634

Country

United States

Facility Name

Teva Investigational Site 046-0133

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Facility Name

Teva Investigational Site 046-0128

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Teva Investigational Site 060-0170

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

Teva Investigational Site 046-0110

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63304

Country

United States

Facility Name

Teva Investigational Site 046-0134

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68526-9467

Country

United States

Facility Name

Teva Investigational Site 046-0109

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Teva Investigational Site 046-0124

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Teva Investigational Site 060-0154

City

New York

State/Province

New York

ZIP/Postal Code

10036

Country

United States

Facility Name

Teva Investigational Site 046-0102

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Teva Investigational Site 046-0106

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Teva Investigational Site 060-0169

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414-5834

Country

United States

Facility Name

Teva Investigational Site 060-0156

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-2551

Country

United States

Facility Name

Teva Investigational Site 046-0113

City

Dallas

State/Province

Texas

ZIP/Postal Code

75243

Country

United States

Facility Name

Teva Investigational Site 060-0163

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Teva Investigational Site 046-0108

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Teva Investigational Site 046-0120

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78249

Country

United States

Facility Name

Teva Investigational Site 046-0105

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Teva Investigational Site 046-0118

City

Petersburg

State/Province

Virginia

ZIP/Postal Code

23805

Country

United States

Facility Name

Teva Investigational Site 060-0162

City

Everett

State/Province

Washington

ZIP/Postal Code

98201-4077

Country

United States

Facility Name

Teva Investigational Site 060-1407

City

Buenos Aires

ZIP/Postal Code

C1023AAB

Country

Argentina

Facility Name

Teva Investigational Site 060-1402

City

Buenos Aires

ZIP/Postal Code

C1425AHQ

Country

Argentina

Facility Name

Teva Investigational Site 060-1403

City

La Plata

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Teva Investigational Site 060-1404

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Teva Investigational Site 060-1802

City

Liverpool

ZIP/Postal Code

2170

Country

Australia

Facility Name

Teva Investigational Site 046-0201

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1Z0M1

Country

Canada

Facility Name

Teva Investigational Site 046-0202

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2G 1W2

Country

Canada

Facility Name

Teva Investigational Site 060-1503

City

Bello

ZIP/Postal Code

051050

Country

Colombia

Facility Name

Teva Investigational Site 060-1504

City

Pereira

ZIP/Postal Code

660003

Country

Colombia

Facility Name

Teva Investigational Site 046-0302

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Teva Investigational Site 046-0301

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Teva Investigational Site 060-0901

City

Budapest

ZIP/Postal Code

1021

Country

Hungary

Facility Name

Teva Investigational Site 060-0902

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Teva Investigational Site 060-1005

City

Cagliari

ZIP/Postal Code

09121

Country

Italy

Facility Name

Teva Investigational Site 060-1001

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Teva Investigational Site 060-1003

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Teva Investigational Site 060-1901

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Teva Investigational Site 060-1903

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Teva Investigational Site 060-1902

City

Seoul

ZIP/Postal Code

6351

Country

Korea, Republic of

Facility Name

Teva Investigational Site 060-1601

City

Culiacan

ZIP/Postal Code

80020

Country

Mexico

Facility Name

Teva Investigational Site 060-1603

City

Leon

ZIP/Postal Code

37000

Country

Mexico

Facility Name

Teva Investigational Site 060-1602

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Teva Investigational Site 060-1604

City

Monterrey

ZIP/Postal Code

64610

Country

Mexico

Facility Name

Teva Investigational Site 060-1104

City

Gdansk

ZIP/Postal Code

80-542

Country

Poland

Facility Name

Teva Investigational Site 060-1101

City

Katowice

ZIP/Postal Code

40-123

Country

Poland

Facility Name

Teva Investigational Site 060-1105

City

Krakow

ZIP/Postal Code

31503

Country

Poland

Facility Name

Teva Investigational Site 060-1102

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Teva Investigational Site 060-1103

City

Warsaw

ZIP/Postal Code

02-793

Country

Poland

Facility Name

Teva Investigational Site 046-0704

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Teva Investigational Site 046-0703

City

Voronezh

ZIP/Postal Code

394024

Country

Russian Federation

Facility Name

Teva Investigational Site 046-1702

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 046-1703

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Teva Investigational Site 046-1701

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Teva Investigational Site 046-0605

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Teva Investigational Site 046-0602

City

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Teva Investigational Site 046-0603

City

Malaga

ZIP/Postal Code

29620

Country

Spain

Facility Name

Teva Investigational Site 046-0601

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Teva Investigational Site 060-2003

City

Dnipropetrovsk

ZIP/Postal Code

49101

Country

Ukraine

Facility Name

Teva Investigational Site 060-2001

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Teva Investigational Site 060-2002

City

Kharkiv

ZIP/Postal Code

61153

Country

Ukraine

Facility Name

Teva Investigational Site 060-2007

City

Kiev

ZIP/Postal Code

4080

Country

Ukraine

Facility Name

Teva Investigational Site 060-2005

City

Kyiv

ZIP/Postal Code

4209

Country

Ukraine

Facility Name

Teva Investigational Site 060-2006

City

Vinnytsia

ZIP/Postal Code

21005

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

We'll reach out to this number within 24 hrs

Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents (ARTISTS)

Tourette Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

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

Learn more about this trial