A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)

NCT03571256 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: TV50717-CNS-300602017-002976-24
• Study Type: interventional
• Target: 158
• Locations: 10 countries
• Sites: 56

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.

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants

  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 (3 levels: Weeks 2, 4, and 8), 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 8

Secondary Outcomes (9)

• 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

  Baseline, Week 8

• Change From Baseline in the TTS of the YGTSS at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants

  Baseline, Week 8

• Change From Baseline in the TS-CGI Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants

  Baseline, Week 8

• 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

  Baseline, Week 8

• Change From Baseline in the TS-PGII Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants

  Baseline, Week 8

Study Arms (3)

TEV-50717 High-Dose

EXPERIMENTAL

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

Drug: TEV-50717; Drug: Placebo

TEV-50717 Low-Dose

EXPERIMENTAL

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

Drug: TEV-50717; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TEV-50717 DRUG

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

Also known as: AUSTEDO, Deutetrabenazine

TEV-50717 High-Dose; TEV-50717 Low-Dose

Placebo DRUG

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

Placebo; TEV-50717 High-Dose; TEV-50717 Low-Dose

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (56)

Teva Investigational Site 060-0160

Gainesville, Florida, 32608, United States

Location

Teva Investigational Site 060-0166

Gulf Breeze, Florida, 32561-4458, United States

Location

Teva Investigational Site 060-0161

Miami, Florida, 33136-2107, United States

Location

Teva Investigational Site 060-0151

Orlando, Florida, 32801, United States

Location

Teva Investigational Site 060-0153

Orlando, Florida, 32819, United States

Location

Teva Investigational Site 060-0168

Atlanta, Georgia, 30329, United States

Location

Teva Investigational Site 060-0155

Chicago, Illinois, 60612, United States

Location

Teva Investigational Site 060-0164

Chicago, Illinois, 60634, United States

Location

Teva Investigational Site 060-0152

Indianapolis, Indiana, 46256, United States

Location

Teva Investigational Site 060-0158

Louisville, Kentucky, 40202, United States

Location

Teva Investigational Site 060-0167

Rockville, Maryland, 20852-4219, United States

Location

Teva Investigational Site 060-0165

Ann Arbor, Michigan, 48105, United States

Location

Teva Investigational Site 060-0170

Bridgeton, Missouri, 63044, United States

Location

Teva Investigational Site 060-0154

New York, New York, 10036, United States

Location

Teva Investigational Site 060-0169

Charleston, South Carolina, 29414-5834, United States

Location

Teva Investigational Site 060-0157

Memphis, Tennessee, 38157, United States

Location

Teva Investigational Site 060-0156

Nashville, Tennessee, 37232-2551, United States

Location

Teva Investigational Site 060-0163

Fort Worth, Texas, 76104, United States

Location

Teva Investigational Site 060-0162

Everett, Washington, 98201-4077, United States

Location

Teva Investigational Site 060-1407

Buenos Aires, C1023AAB, Argentina

Location

Teva Investigational Site 060-1401

Buenos Aires, C1058AAJ, Argentina

Location

Teva Investigational Site 060-1402

Buenos Aires, C1425AHQ, Argentina

Location

Teva Investigational Site 060-1403

La Plata, 1900, Argentina

Location

Teva Investigational Site 060-1404

Mendoza, 5500, Argentina

Location

Teva Investigational Site 060-1802

Liverpool, 2170, Australia

Location

Teva Investigational Site 060-1801

Parkville, 3052, Australia

Location

Teva Investigational Site 060-1503

Bello, 051050, Colombia

Location

Teva Investigational Site 060-1501

Medellín, 5500515, Colombia

Location

Teva Investigational Site 060-1506

Medellín, 78 B 50, Colombia

Location

Teva Investigational Site 060-1504

Pereira, 660003, Colombia

Location

Teva Investigational Site 060-0901

Budapest, 1021, Hungary

Location

Teva Investigational Site 060-0902

Szeged, 6725, Hungary

Location

Teva Investigational Site 060-1005

Cagliari, 09121, Italy

Location

Teva Investigational Site 060-1001

Catania, 95123, Italy

Location

Teva Investigational Site 060-1003

Naples, 80131, Italy

Location

Teva Investigational Site 060-1004

Rome, 00165, Italy

Location

Teva Investigational Site 060-1601

Culiacán, 80020, Mexico

Location

Teva Investigational Site 060-1603

León, 37000, Mexico

Location

Teva Investigational Site 060-1602

Monterrey, 64460, Mexico

Location

Teva Investigational Site 060-1604

Monterrey, 64610, Mexico

Location

Teva Investigational Site 060-1104

Gdansk, 80-542, Poland

Location

Teva Investigational Site 060-1101

Katowice, 40-123, Poland

Location

Teva Investigational Site 060-1105

Krakow, 31503, Poland

Location

Teva Investigational Site 060-1102

Poznan, 60-693, Poland

Location

Teva Investigational Site 060-1106

Torun, 87-100, Poland

Location

Teva Investigational Site 060-1103

Warsaw, 02-793, Poland

Location

Teva Investigational Site 060-1901

Seoul, 110-744, South Korea

Location

Teva Investigational Site 060-1903

Seoul, 138-736, South Korea

Location

Teva Investigational Site 060-1904

Seoul, 3722, South Korea

Location

Teva Investigational Site 060-1902

Seoul, 6351, South Korea

Location

Teva Investigational Site 060-2003

Dnipropetrovsk, 49101, Ukraine

Location

Teva Investigational Site 060-2001

Kharkiv, 61068, Ukraine

Location

Teva Investigational Site 060-2002

Kharkiv, 61153, Ukraine

Location

Teva Investigational Site 060-2007

Kiev, 4080, Ukraine

Location

Teva Investigational Site 060-2005

Kyiv, 4209, Ukraine

Location

Teva Investigational Site 060-2006

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 34661664 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 3
• 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: June 18, 2018
• First Posted: June 27, 2018
• Study Start: May 31, 2018
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: November 9, 2021
• Results First Posted: June 9, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

AR (5); UA (6); AU (2); ME (4); PL (6); CO (4); KR (4); US (19); IT (4); HU (2)