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

NCT ID: NCT03571256

Last Updated: 2021-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-12-09

Brief Summary

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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.

Detailed Description

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Conditions

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Tourette Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TEV-50717 High-Dose

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

Group Type EXPERIMENTAL

TEV-50717

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

TEV-50717 Low-Dose

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

Group Type EXPERIMENTAL

TEV-50717

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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TEV-50717

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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AUSTEDO, Deutetrabenazine

Eligibility Criteria

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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

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nuvelution TS Pharma, Inc.

INDUSTRY

Sponsor Role collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 060-0160

Gainesville, Florida, United States

Site Status

Teva Investigational Site 060-0166

Gulf Breeze, Florida, United States

Site Status

Teva Investigational Site 060-0161

Miami, Florida, United States

Site Status

Teva Investigational Site 060-0151

Orlando, Florida, United States

Site Status

Teva Investigational Site 060-0153

Orlando, Florida, United States

Site Status

Teva Investigational Site 060-0168

Atlanta, Georgia, United States

Site Status

Teva Investigational Site 060-0155

Chicago, Illinois, United States

Site Status

Teva Investigational Site 060-0164

Chicago, Illinois, United States

Site Status

Teva Investigational Site 060-0152

Indianapolis, Indiana, United States

Site Status

Teva Investigational Site 060-0158

Louisville, Kentucky, United States

Site Status

Teva Investigational Site 060-0167

Rockville, Maryland, United States

Site Status

Teva Investigational Site 060-0165

Ann Arbor, Michigan, United States

Site Status

Teva Investigational Site 060-0170

Bridgeton, Missouri, United States

Site Status

Teva Investigational Site 060-0154

New York, New York, United States

Site Status

Teva Investigational Site 060-0169

Charleston, South Carolina, United States

Site Status

Teva Investigational Site 060-0157

Memphis, Tennessee, United States

Site Status

Teva Investigational Site 060-0156

Nashville, Tennessee, United States

Site Status

Teva Investigational Site 060-0163

Fort Worth, Texas, United States

Site Status

Teva Investigational Site 060-0162

Everett, Washington, United States

Site Status

Teva Investigational Site 060-1407

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 060-1401

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 060-1402

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 060-1403

La Plata, , Argentina

Site Status

Teva Investigational Site 060-1404

Mendoza, , Argentina

Site Status

Teva Investigational Site 060-1802

Liverpool, , Australia

Site Status

Teva Investigational Site 060-1801

Parkville, , Australia

Site Status

Teva Investigational Site 060-1503

Bello, , Colombia

Site Status

Teva Investigational Site 060-1501

Medellín, , Colombia

Site Status

Teva Investigational Site 060-1506

Medellín, , Colombia

Site Status

Teva Investigational Site 060-1504

Pereira, , Colombia

Site Status

Teva Investigational Site 060-0901

Budapest, , Hungary

Site Status

Teva Investigational Site 060-0902

Szeged, , Hungary

Site Status

Teva Investigational Site 060-1005

Cagliari, , Italy

Site Status

Teva Investigational Site 060-1001

Catania, , Italy

Site Status

Teva Investigational Site 060-1003

Naples, , Italy

Site Status

Teva Investigational Site 060-1004

Rome, , Italy

Site Status

Teva Investigational Site 060-1601

Culiacán, , Mexico

Site Status

Teva Investigational Site 060-1603

León, , Mexico

Site Status

Teva Investigational Site 060-1602

Monterrey, , Mexico

Site Status

Teva Investigational Site 060-1604

Monterrey, , Mexico

Site Status

Teva Investigational Site 060-1104

Gdansk, , Poland

Site Status

Teva Investigational Site 060-1101

Katowice, , Poland

Site Status

Teva Investigational Site 060-1105

Krakow, , Poland

Site Status

Teva Investigational Site 060-1102

Poznan, , Poland

Site Status

Teva Investigational Site 060-1106

Torun, , Poland

Site Status

Teva Investigational Site 060-1103

Warsaw, , Poland

Site Status

Teva Investigational Site 060-1901

Seoul, , South Korea

Site Status

Teva Investigational Site 060-1903

Seoul, , South Korea

Site Status

Teva Investigational Site 060-1904

Seoul, , South Korea

Site Status

Teva Investigational Site 060-1902

Seoul, , South Korea

Site Status

Teva Investigational Site 060-2003

Dnipropetrovsk, , Ukraine

Site Status

Teva Investigational Site 060-2001

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 060-2002

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 060-2007

Kiev, , Ukraine

Site Status

Teva Investigational Site 060-2005

Kyiv, , Ukraine

Site Status

Teva Investigational Site 060-2006

Vinnytsia, , Ukraine

Site Status

Countries

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United States Argentina Australia Colombia Hungary Italy Mexico Poland South Korea Ukraine

References

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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.

Reference Type DERIVED
PMID: 34661664 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-002976-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV50717-CNS-30060

Identifier Type: -

Identifier Source: org_study_id