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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03571256




Registration number
NCT03571256
Ethics application status
Date submitted
18/06/2018
Date registered
27/06/2018
Date last updated
9/11/2021

Titles & IDs
Public title
A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)
Scientific title
A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome
Secondary ID [1] 0 0
2017-002976-24
Secondary ID [2] 0 0
TV50717-CNS-30060
Universal Trial Number (UTN)
Trial acronym
ARTISTS2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tourette Syndrome 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TEV-50717
Treatment: Drugs - Placebo

Experimental: TEV-50717 High-Dose - TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks

Experimental: TEV-50717 Low-Dose - TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks

Placebo comparator: Placebo - Placebo matched to TEV-50717 for a total of 8 weeks


Treatment: Drugs: TEV-50717
6-, 9-, 12-, 15-, and 18 mg oral tablets

Treatment: Drugs: Placebo
Placebo matched to TEV-50717 tablets will be taken BID.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [1] 0 0
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [2] 0 0
Change From Baseline in the TTS of the YGTSS at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [2] 0 0
Baseline, Week 8
Secondary outcome [3] 0 0
Change From Baseline in the TS-CGI Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [3] 0 0
Baseline, Week 8
Secondary outcome [4] 0 0
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [4] 0 0
Baseline, Week 8
Secondary outcome [5] 0 0
Change From Baseline in the TS-PGII Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [5] 0 0
Baseline, Week 8
Secondary outcome [6] 0 0
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 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [6] 0 0
Baseline, Week 8
Secondary outcome [7] 0 0
Change From Baseline in the C&A-GTS-QOL ADL Subscale Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Timepoint [7] 0 0
Baseline, Week 8
Secondary outcome [8] 0 0
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version and Self-reported Version) Total Score at Week 9
Timepoint [8] 0 0
Baseline, Week 9
Secondary outcome [9] 0 0
Number of Participants at Baseline and Week 9 With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)
Timepoint [9] 0 0
Baseline, Week 9

Eligibility
Key inclusion criteria
* Participant weighs at least 44 pounds (20 kg) at baseline.
* Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the participant's active tics are causing distress or impairment.
* Participant has a TTS of 20 or higher on the YGTSS at screening and baseline.
* Participant is able to swallow study medication whole.
* -Additional criteria apply, please contact the investigator for more information
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
* The participant 's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum 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 a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
* Participant has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
* Participant has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics.
* Participant has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
* Participant has participated in an investigational drug or device study and received investigational medicinal product (IMP)/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
* Participant is a pregnant or lactating female, or plans to be pregnant during the study.
* -Additional criteria apply, please contact the investigator for more information

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/12/2019
Sample size
Target
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 060-1802 - Liverpool
Recruitment hospital [2] 0 0
Teva Investigational Site 060-1801 - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
La Plata
Country [16] 0 0
Argentina
State/province [16] 0 0
Mendoza
Country [17] 0 0
Colombia
State/province [17] 0 0
Bello
Country [18] 0 0
Colombia
State/province [18] 0 0
Medellin
Country [19] 0 0
Colombia
State/province [19] 0 0
Pereira
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Szeged
Country [22] 0 0
Italy
State/province [22] 0 0
Cagliari
Country [23] 0 0
Italy
State/province [23] 0 0
Catania
Country [24] 0 0
Italy
State/province [24] 0 0
Naples
Country [25] 0 0
Italy
State/province [25] 0 0
Rome
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Mexico
State/province [27] 0 0
Culiacan
Country [28] 0 0
Mexico
State/province [28] 0 0
Leon
Country [29] 0 0
Mexico
State/province [29] 0 0
Monterrey
Country [30] 0 0
Poland
State/province [30] 0 0
Gdansk
Country [31] 0 0
Poland
State/province [31] 0 0
Katowice
Country [32] 0 0
Poland
State/province [32] 0 0
Krakow
Country [33] 0 0
Poland
State/province [33] 0 0
Poznan
Country [34] 0 0
Poland
State/province [34] 0 0
Torun
Country [35] 0 0
Poland
State/province [35] 0 0
Warsaw
Country [36] 0 0
Ukraine
State/province [36] 0 0
Dnipropetrovsk
Country [37] 0 0
Ukraine
State/province [37] 0 0
Kharkiv
Country [38] 0 0
Ukraine
State/province [38] 0 0
Kiev
Country [39] 0 0
Ukraine
State/province [39] 0 0
Kyiv
Country [40] 0 0
Ukraine
State/province [40] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Nuvelution TS Pharma, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Standard placebo-controlled, double-blind study design (TEV-50717 \[low dose and high dose\] vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in a statistically significant effect on the tics in participants with TS.
Trial website
https://clinicaltrials.gov/study/NCT03571256
Trial related presentations / publications
Coffey B, Jankovic J, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander JK, Barkay H, Harary E. Efficacy and Safety of Fixed-Dose Deutetrabenazine in Children and Adolescents for Tics Associated With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2129397. doi: 10.1001/jamanetworkopen.2021.29397.
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
Teva Branded Pharmaceutical Products R&D, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03571256