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

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Brief Title

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

Official Title

A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 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

Condition

Tourette Syndrome

Intervention

TEV-50717

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

158

Start Date

May 31, 2018

Completion Date

December 9, 2019

Primary Completion Date

December 9, 2019

Eligibility Criteria

        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

Gender

All

Ages

6 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Teva Medical Expert, MD, ,

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations

NCT ID

NCT03571256

Organization ID

TV50717-CNS-30060

Secondary IDs

2017-002976-24

Responsible Party

Sponsor

Study Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

 Nuvelution TS Pharma, Inc.

Study Sponsor

Teva Medical Expert, MD, Study Director, Teva Pharmaceuticals USA

Verification Date

August 2020