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

Tourette Syndrome Clinical Trial

— ARTISTS1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452943
• Other study ID #: TV50717-CNS-30046
• Secondary ID: 2016-000622-19
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 5, 2018
• Est. completion date: November 12, 2019

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Drug:
• TEV-50717
6, 9, 12, 15, and 18 mg oral tablets
• Placebo
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.

Locations

Country	Name	City	State
Canada	Teva Investigational Site 046-0201	Ajax	Ontario
Canada	Teva Investigational Site 046-0202	Ottawa	Ontario
Denmark	Teva Investigational Site 046-0302	Herlev
Denmark	Teva Investigational Site 046-0301	Odense
Russian Federation	Teva Investigational Site 046-0702	Stavropol
Russian Federation	Teva Investigational Site 046-0704	Tomsk
Russian Federation	Teva Investigational Site 046-0703	Voronezh
Serbia	Teva Investigational Site 046-1702	Belgrade
Serbia	Teva Investigational Site 046-1703	Belgrade
Serbia	Teva Investigational Site 046-1701	Novi Sad
Spain	Teva Investigational Site 046-0604	Barcelona
Spain	Teva Investigational Site 046-0602	Madrid
Spain	Teva Investigational Site 046-0605	Madrid
Spain	Teva Investigational Site 046-0603	Malaga
Spain	Teva Investigational Site 046-0601	Sevilla
United States	Teva Investigational Site 046-0126	Anaheim	California
United States	Teva Investigational Site 046-0116	Atlanta	Georgia
United States	Teva Investigational Site 046-0128	Boston	Massachusetts
United States	Teva Investigational Site 046-0113	Dallas	Texas
United States	Teva Investigational Site 046-0104	Dothan	Alabama
United States	Teva Investigational Site 046-0103	Houston	Texas
United States	Teva Investigational Site 046-0108	Houston	Texas
United States	Teva Investigational Site 046-0134	Lincoln	Nebraska
United States	Teva Investigational Site 046-0132	Miami	Florida
United States	Teva Investigational Site 046-0133	Naperville	Illinois
United States	Teva Investigational Site 046-0124	New York	New York
United States	Teva Investigational Site 046-0106	Oklahoma City	Oklahoma
United States	Teva Investigational Site 046-0105	Orem	Utah
United States	Teva Investigational Site 046-0115	Orlando	Florida
United States	Teva Investigational Site 046-0118	Petersburg	Virginia
United States	Teva Investigational Site 046-0125	Raleigh	North Carolina
United States	Teva Investigational Site 046-0102	Rochester	New York
United States	Teva Investigational Site 046-0112	Rochester	New York
United States	Teva Investigational Site 046-0107	Rogers	Arkansas
United States	Teva Investigational Site 046-0101	Sacramento	California
United States	Teva Investigational Site 046-0110	Saint Charles	Missouri
United States	Teva Investigational Site 046-0114	Saint Petersburg	Florida
United States	Teva Investigational Site 046-0120	San Antonio	Texas
United States	Teva Investigational Site 046-0111	San Diego	California
United States	Teva Investigational Site 046-0130	Santa Ana	California
United States	Teva Investigational Site 046-0117	Sun City	Arizona
United States	Teva Investigational Site 046-0109	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.	Nuvelution TS Pharma, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Russian Federation,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the TTS of the YGTSS at 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	Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at 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
Secondary	Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at 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
Secondary	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	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
Secondary	Percentage of Participants With Adverse Events	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)