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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03567291




Registration number
NCT03567291
Ethics application status
Date submitted
12/06/2018
Date registered
25/06/2018

Titles & IDs
Public title
Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents
Scientific 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
Secondary ID [1] 0 0
2016-000630-22
Secondary ID [2] 0 0
TV50717-CNS-30047
Universal Trial Number (UTN)
Trial acronym
ARTISTS
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- Part A - 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.

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

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


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

Treatment: Drugs: Placebo
Placebo comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined
Timepoint [1] 0 0
Day 1 to Week 55
Primary outcome [2] 0 0
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II)
Timepoint [2] 0 0
Weeks 28 to 30
Primary outcome [3] 0 0
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score
Timepoint [3] 0 0
Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
Primary outcome [4] 0 0
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score
Timepoint [4] 0 0
Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
Primary outcome [5] 0 0
Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30
Timepoint [5] 0 0
Week 28, Week 30
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
Week 28, Week 30
Primary outcome [7] 0 0
Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)
Timepoint [7] 0 0
Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
Primary outcome [8] 0 0
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
Timepoint [8] 0 0
Week 28, Week 30
Secondary outcome [1] 0 0
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)
Timepoint [1] 0 0
Baseline, Weeks 8, 15, 28, 41, 54, and 55
Secondary outcome [2] 0 0
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score
Timepoint [2] 0 0
Baseline, Weeks 8, 15, 28, 41, 54, and 55
Secondary outcome [3] 0 0
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score
Timepoint [3] 0 0
Baseline, Weeks 8, 15, 28, 41, 54, and 55
Secondary outcome [4] 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
Timepoint [4] 0 0
Baseline, Weeks 6, 28, 34, 54
Secondary outcome [5] 0 0
Change From Randomized Withdrawal Baseline (Week 28) in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) to Week 30
Timepoint [5] 0 0
Week 28, Week 30

Eligibility
Key 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
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2020
Sample size
Target
Accrual to date
Final
228
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 060-1802 - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
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
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
La Plata
Country [21] 0 0
Argentina
State/province [21] 0 0
Mendoza
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Colombia
State/province [23] 0 0
Bello
Country [24] 0 0
Colombia
State/province [24] 0 0
Pereira
Country [25] 0 0
Denmark
State/province [25] 0 0
Herlev
Country [26] 0 0
Denmark
State/province [26] 0 0
Odense
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Szeged
Country [29] 0 0
Italy
State/province [29] 0 0
Cagliari
Country [30] 0 0
Italy
State/province [30] 0 0
Catania
Country [31] 0 0
Italy
State/province [31] 0 0
Naples
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Mexico
State/province [33] 0 0
Culiacan
Country [34] 0 0
Mexico
State/province [34] 0 0
Leon
Country [35] 0 0
Mexico
State/province [35] 0 0
Monterrey
Country [36] 0 0
Poland
State/province [36] 0 0
Gdansk
Country [37] 0 0
Poland
State/province [37] 0 0
Katowice
Country [38] 0 0
Poland
State/province [38] 0 0
Krakow
Country [39] 0 0
Poland
State/province [39] 0 0
Poznan
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Tomsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Voronezh
Country [43] 0 0
Serbia
State/province [43] 0 0
Belgrade
Country [44] 0 0
Serbia
State/province [44] 0 0
Novi Sad
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Malaga
Country [47] 0 0
Spain
State/province [47] 0 0
Sevilla
Country [48] 0 0
Ukraine
State/province [48] 0 0
Dnipropetrovsk
Country [49] 0 0
Ukraine
State/province [49] 0 0
Kharkiv
Country [50] 0 0
Ukraine
State/province [50] 0 0
Kiev
Country [51] 0 0
Ukraine
State/province [51] 0 0
Kyiv
Country [52] 0 0
Ukraine
State/province [52] 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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03567291