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