Last updated on January 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Tourette's Disorder
  • Age: Between 6 - 16 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patient weighs at least 44 pounds (20 kg) at baseline.
  • Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for TS and, in the opinion of the investigator, patient, and parent/legal guardian, the patient's active tics are causing distress or impairment.
  • Patient has a TTS of 20 or higher on the YGTSS at screening and baseline.
  • Patient is able to swallow study medication whole.
  • -Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Patient has a neurologic disorder other than TS that could obscure the evaluation of tics.
  • The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
  • Patient has clinically significant depression at screening or baseline.
  • Patient has a history of suicidal intent or related behaviors within 2 years of screening
  • Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
  • Patient has a first-degree relative who has completed suicide.
  • Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
  • Patient has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for OCD within 4 weeks of screening.
  • Patient 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.
  • Patient has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
  • Patient has participated in an investigational drug or device study and received IMP/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
  • Patient is a pregnant or lactating female, or plans to be pregnant during the study.
  • -Additional criteria apply, please contact the investigator for more information

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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