Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents (ARTISTS1)

November 5, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1Z0M1
        • Teva Investigational Site 046-0201
      • Ottawa, Ontario, Canada, K2G 1W2
        • Teva Investigational Site 046-0202
  • Denmark
      • Herlev, Denmark, 2730
        • Teva Investigational Site 046-0302
      • Odense, Denmark, 5000
        • Teva Investigational Site 046-0301
  • Russian Federation
      • Stavropol, Russian Federation, 355038
        • Teva Investigational Site 046-0702
      • Tomsk, Russian Federation, 634050
        • Teva Investigational Site 046-0704
      • Voronezh, Russian Federation, 394024
        • Teva Investigational Site 046-0703
  • Serbia
      • Belgrade, Serbia, 11000
        • Teva Investigational Site 046-1702
      • Belgrade, Serbia, 11000
        • Teva Investigational Site 046-1703
      • Novi Sad, Serbia, 21000
        • Teva Investigational Site 046-1701
  • Spain
      • Barcelona, Spain, 08041
        • Teva Investigational Site 046-0604
      • Madrid, Spain, 28009
        • Teva Investigational Site 046-0605
      • Madrid, Spain, 28922
        • Teva Investigational Site 046-0602
      • Malaga, Spain, 29620
        • Teva Investigational Site 046-0603
      • Sevilla, Spain, 41013
        • Teva Investigational Site 046-0601
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Teva Investigational Site 046-0104
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Teva Investigational Site 046-0117
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Teva Investigational Site 046-0107
    • California
      • Anaheim, California, United States, 92805
        • Teva Investigational Site 046-0126
      • Sacramento, California, United States, 95815
        • Teva Investigational Site 046-0101
      • San Diego, California, United States, 92108
        • Teva Investigational Site 046-0111
      • Santa Ana, California, United States, 92705
        • Teva Investigational Site 046-0130
    • Florida
      • Miami, Florida, United States, 33155
        • Teva Investigational Site 046-0132
      • Orlando, Florida, United States, 32803
        • Teva Investigational Site 046-0115
      • Saint Petersburg, Florida, United States, 33701
        • Teva Investigational Site 046-0114
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Teva Investigational Site 046-0116
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Teva Investigational Site 046-0133
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Teva Investigational Site 046-0128
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Teva Investigational Site 046-0110
    • Nebraska
      • Lincoln, Nebraska, United States, 68526-9467
        • Teva Investigational Site 046-0134
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Teva Investigational Site 046-0109
    • New York
      • New York, New York, United States, 10029
        • Teva Investigational Site 046-0124
      • Rochester, New York, United States, 14618
        • Teva Investigational Site 046-0102
      • Rochester, New York, United States, 14642
        • Teva Investigational Site 046-0112
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Teva Investigational Site 046-0125
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Teva Investigational Site 046-0106
    • Texas
      • Dallas, Texas, United States, 75243
        • Teva Investigational Site 046-0113
      • Houston, Texas, United States, 77030
        • Teva Investigational Site 046-0108
      • Houston, Texas, United States, 77090
        • Teva Investigational Site 046-0103
      • San Antonio, Texas, United States, 78249
        • Teva Investigational Site 046-0120
    • Utah
      • Orem, Utah, United States, 84058
        • Teva Investigational Site 046-0105
    • Virginia
      • Petersburg, Virginia, United States, 23805
        • Teva Investigational Site 046-0118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is 6 to 16 years of age, inclusive.
  • Participant weighs at least 44 pounds (20 kilograms [kg]).
  • The participant's active tics are causing distress or impairment.
  • Participant is able to swallow study medication whole.
  • Participant 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:

  • Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
  • Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
  • Participant has clinically significant depression at screening or baseline.
  • Participant has a history of suicidal intent or related behaviors within 2 years of screening.
  • Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
  • Participant has a first-degree relative who has completed suicide.
  • Participant has received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
  • Participant has an unstable or serious medical illness at screening or baseline.

  • Participant is pregnant or breastfeeding.

    • Additional criteria apply, please contact the investigator for more information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TEV-50717
TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks
Drug: TEV-50717
6, 9, 12, 15, and 18 mg oral tablets
Other Names:
  • Deutetrabenazine
Drug: Placebo
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
Placebo Comparator: Placebo
Placebo matched to TEV-50717 BID for a total of 12 weeks
Drug: Placebo
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the TTS of the YGTSS at Week 12
Time Frame: Baseline, Week 12
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. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12
Time Frame: Baseline, Week 12
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. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.
Baseline, Week 12
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12
Time Frame: Baseline, Week 12
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, Week 12
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 at Week 12
Time Frame: Baseline, Week 12
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. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6-11 years, 12-16 years) as covariates.
Baseline, Week 12
Percentage of Participants With Adverse Events
Time Frame: Baseline (Day 1) to follow-up (Week 14)
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. 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.
Baseline (Day 1) to follow-up (Week 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nuvelution TS Pharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV50717-CNS-30046
  • 2016-000622-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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