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

• Status: Completed
• Trial end date: 2019-12-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Collaborator: Nuvelution TS Pharma, Inc.
• Treatments: Tetrabenazine

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