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

NCT03452943 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: TV50717-CNS-300462016-000622-19
• Study Type: interventional
• Target: 119
• Locations: 6 countries
• Sites: 42

Brief 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.

Conditions

Tourette Syndrome

Keywords

Tourette Syndrome; adolescents; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12

  Baseline, Week 12

• Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12

  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

  Baseline, Week 12

• Percentage of Participants With Adverse Events

  Baseline (Day 1) to follow-up (Week 14)

Study Arms (2)

TEV-50717

EXPERIMENTAL

TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks

Drug: TEV-50717; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo matched to TEV-50717 BID for a total of 12 weeks

Drug: Placebo

Interventions

TEV-50717 DRUG

6, 9, 12, 15, and 18 mg oral tablets

Also known as: Deutetrabenazine

TEV-50717

Placebo DRUG

Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.

Placebo; TEV-50717

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• Nuvelution TS Pharma, Inc.: collaborator

Study Sites (42)

Teva Investigational Site 046-0104

Dothan, Alabama, 36303, United States

Location

Teva Investigational Site 046-0117

Sun City, Arizona, 85351, United States

Location

Teva Investigational Site 046-0107

Rogers, Arkansas, 72758, United States

Location

Teva Investigational Site 046-0126

Anaheim, California, 92805, United States

Location

Teva Investigational Site 046-0101

Sacramento, California, 95815, United States

Location

Teva Investigational Site 046-0111

San Diego, California, 92108, United States

Location

Teva Investigational Site 046-0130

Santa Ana, California, 92705, United States

Location

Teva Investigational Site 046-0132

Miami, Florida, 33155, United States

Location

Teva Investigational Site 046-0115

Orlando, Florida, 32803, United States

Location

Teva Investigational Site 046-0114

St. Petersburg, Florida, 33701, United States

Location

Teva Investigational Site 046-0116

Atlanta, Georgia, 30331, United States

Location

Teva Investigational Site 046-0133

Naperville, Illinois, 60563, United States

Location

Teva Investigational Site 046-0128

Boston, Massachusetts, 02114, United States

Location

Teva Investigational Site 046-0110

Saint Charles, Missouri, 63304, United States

Location

Teva Investigational Site 046-0134

Lincoln, Nebraska, 68526-9467, United States

Location

Teva Investigational Site 046-0109

Voorhees Township, New Jersey, 08043, United States

Location

Teva Investigational Site 046-0124

New York, New York, 10029, United States

Location

Teva Investigational Site 046-0102

Rochester, New York, 14618, United States

Location

Teva Investigational Site 046-0112

Rochester, New York, 14642, United States

Location

Teva Investigational Site 046-0125

Raleigh, North Carolina, 27607, United States

Location

Teva Investigational Site 046-0106

Oklahoma City, Oklahoma, 73116, United States

Location

Teva Investigational Site 046-0113

Dallas, Texas, 75243, United States

Location

Teva Investigational Site 046-0108

Houston, Texas, 77030, United States

Location

Teva Investigational Site 046-0103

Houston, Texas, 77090, United States

Location

Teva Investigational Site 046-0120

San Antonio, Texas, 78249, United States

Location

Teva Investigational Site 046-0105

Orem, Utah, 84058, United States

Location

Teva Investigational Site 046-0118

Petersburg, Virginia, 23805, United States

Location

Teva Investigational Site 046-0201

Ajax, Ontario, L1Z0M1, Canada

Location

Teva Investigational Site 046-0202

Ottawa, Ontario, K2G 1W2, Canada

Location

Teva Investigational Site 046-0302

Herlev, 2730, Denmark

Location

Teva Investigational Site 046-0301

Odense, 5000, Denmark

Location

Teva Investigational Site 046-0702

Stavropol, 355038, Russia

Location

Teva Investigational Site 046-0704

Tomsk, 634050, Russia

Location

Teva Investigational Site 046-0703

Voronezh, 394024, Russia

Location

Teva Investigational Site 046-1702

Belgrade, 11000, Serbia

Location

Teva Investigational Site 046-1703

Belgrade, 11000, Serbia

Location

Teva Investigational Site 046-1701

Novi Sad, 21000, Serbia

Location

Teva Investigational Site 046-0604

Barcelona, 08041, Spain

Location

Teva Investigational Site 046-0605

Madrid, 28009, Spain

Location

Teva Investigational Site 046-0602

Madrid, 28922, Spain

Location

Teva Investigational Site 046-0603

Málaga, 29620, Spain

Location

Teva Investigational Site 046-0601

Seville, 41013, Spain

Location

Related Publications (1)

• Jankovic J, Coffey B, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander J, Barkay H, Harary E. Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128204. doi: 10.1001/jamanetworkopen.2021.28204.

  PMID: 34609495 DERIVED

MeSH Terms

Conditions

Tourette Syndrome

Interventions

deutetrabenazine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: February 5, 2018
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: November 9, 2021
• Results First Posted: June 4, 2020

Record last verified: 2021-11

Locations

RU (3); DK (2); CA (2); SE (3); US (27); ES (5)