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

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Brief Title

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

Official Title

An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

Brief 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.
    

Detailed Description

      This is an otherwise open-label, single-arm study (Part A) that includes a 2-week,
      double-blind, placebo controlled, randomized drug withdrawal period (Part B) followed by a 3
      week blinded maintenance or re-titration (Part A resumed), 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 (SD-809-C-17 [Phase 1b], TV50717-CNS 30046 [Phase 2/3], or TV50717-CNS 30060 [Phase
      3]).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined

Secondary Outcome

 Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)

Condition

Tourette Syndrome

Intervention

TEV-50717

Study Arms / Comparison Groups

 TEV-50717- Part A
Description:  All patients will undergo TEV-50717 dose titration in this study. Patients will receive 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose will be determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study.

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

228

Start Date

May 25, 2018

Completion Date

May 15, 2020

Primary Completion Date

May 15, 2020

Eligibility 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
      

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Teva Medical Expert, MD, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT03567291

Organization ID

TV50717-CNS-30047

Secondary IDs

2016-000630-22

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

February 2021