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 Branded Pharmaceutical Products R&D, Inc.
Verification Date
November 2021