- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452943
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
Phase
- 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
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Ontario
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Ajax, Ontario, Canada, L1Z0M1
- Teva Investigational Site 046-0201
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Ottawa, Ontario, Canada, K2G 1W2
- Teva Investigational Site 046-0202
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Herlev, Denmark, 2730
- Teva Investigational Site 046-0302
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Odense, Denmark, 5000
- Teva Investigational Site 046-0301
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Stavropol, Russian Federation, 355038
- Teva Investigational Site 046-0702
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Tomsk, Russian Federation, 634050
- Teva Investigational Site 046-0704
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Voronezh, Russian Federation, 394024
- Teva Investigational Site 046-0703
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Belgrade, Serbia, 11000
- Teva Investigational Site 046-1702
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Belgrade, Serbia, 11000
- Teva Investigational Site 046-1703
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Novi Sad, Serbia, 21000
- Teva Investigational Site 046-1701
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Barcelona, Spain, 08041
- Teva Investigational Site 046-0604
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Madrid, Spain, 28009
- Teva Investigational Site 046-0605
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Madrid, Spain, 28922
- Teva Investigational Site 046-0602
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Malaga, Spain, 29620
- Teva Investigational Site 046-0603
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Sevilla, Spain, 41013
- Teva Investigational Site 046-0601
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Alabama
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Dothan, Alabama, United States, 36303
- Teva Investigational Site 046-0104
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Arizona
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Sun City, Arizona, United States, 85351
- Teva Investigational Site 046-0117
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Arkansas
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Rogers, Arkansas, United States, 72758
- Teva Investigational Site 046-0107
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California
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Anaheim, California, United States, 92805
- Teva Investigational Site 046-0126
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Sacramento, California, United States, 95815
- Teva Investigational Site 046-0101
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San Diego, California, United States, 92108
- Teva Investigational Site 046-0111
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Santa Ana, California, United States, 92705
- Teva Investigational Site 046-0130
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Florida
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Miami, Florida, United States, 33155
- Teva Investigational Site 046-0132
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Orlando, Florida, United States, 32803
- Teva Investigational Site 046-0115
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Saint Petersburg, Florida, United States, 33701
- Teva Investigational Site 046-0114
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Georgia
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Atlanta, Georgia, United States, 30331
- Teva Investigational Site 046-0116
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Illinois
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Naperville, Illinois, United States, 60563
- Teva Investigational Site 046-0133
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Teva Investigational Site 046-0128
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Missouri
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Saint Charles, Missouri, United States, 63304
- Teva Investigational Site 046-0110
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Nebraska
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Lincoln, Nebraska, United States, 68526-9467
- Teva Investigational Site 046-0134
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New Jersey
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Voorhees, New Jersey, United States, 08043
- Teva Investigational Site 046-0109
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New York
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New York, New York, United States, 10029
- Teva Investigational Site 046-0124
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Rochester, New York, United States, 14618
- Teva Investigational Site 046-0102
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Rochester, New York, United States, 14642
- Teva Investigational Site 046-0112
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North Carolina
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Raleigh, North Carolina, United States, 27607
- Teva Investigational Site 046-0125
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
- Teva Investigational Site 046-0106
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Texas
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Dallas, Texas, United States, 75243
- Teva Investigational Site 046-0113
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Houston, Texas, United States, 77030
- Teva Investigational Site 046-0108
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Houston, Texas, United States, 77090
- Teva Investigational Site 046-0103
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San Antonio, Texas, United States, 78249
- Teva Investigational Site 046-0120
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Utah
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Orem, Utah, United States, 84058
- Teva Investigational Site 046-0105
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Virginia
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Petersburg, Virginia, United States, 23805
- Teva Investigational Site 046-0118
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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
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 |
Intervention / Treatment |
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Experimental: TEV-50717
TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks
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6, 9, 12, 15, and 18 mg oral tablets
Other Names:
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
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Placebo Comparator: Placebo
Placebo matched to TEV-50717 BID for a total of 12 weeks
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Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in the TTS of the YGTSS at Week 12
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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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
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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.
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Baseline, Week 12
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Percentage of Participants With Adverse Events
Time Frame: Baseline (Day 1) to follow-up (Week 14)
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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.
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Baseline (Day 1) to follow-up (Week 14)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
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)
February 5, 2018
Primary Completion (Actual)
November 12, 2019
Study Completion (Actual)
November 12, 2019
Study Registration Dates
First Submitted
February 26, 2018
First Submitted That Met QC Criteria
February 26, 2018
First Posted (Actual)
March 2, 2018
Study Record Updates
Last Update Posted (Actual)
November 9, 2021
Last Update Submitted That Met QC Criteria
November 5, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
Other Study ID 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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