Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

• Status: Terminated
• Trial end date: 2020-05-15
• Target enrollment: 0
• Participant gender: All

Summary

This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.

• 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:

• Patient is younger than 18 years of age on day 1

• Patient weighs at least 44 pounds (20 kg)

• The patient's active tics are causing distress or impairment

• Patient is able to swallow study medication whole

• Patient is in good general health

• Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study -- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• Patient is 18 years of age or older.

• 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 a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.

• Patient has clinically significant depression at screening or day 1. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.

• 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 clinically significant obsessive-compulsive disorder (OCD) on day 1 that, in the opinion of the investigator, is the primary cause of impairment.

• 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 for reduction of tics within 4 weeks of the screening visit.

• Patient has an unstable or serious medical illness at screening or day 1

• Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.

• Patient has received a monoamine oxidase inhibitor within 14 days of the day 1 visit.

• Patient has participated in an investigational drug or device study (with the exception of Study SD-809-C-17, Study TV50717-CNS-30046, or Study TV50717-CNS-30060) and received IMP/intervention within 30 days or 5 drug half-lives of day 1, whichever is longer.

• The patient is a pregnant or lactating female, or plans to become pregnant during the study.

• Patient has a history of, or acknowledges, alcohol-related disorder in the previous 12 months -- Additional criteria apply, please contact the investigator for more information