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

Teva Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Tourette Syndrome

Treatments

Drug: Placebo

Drug: TEV-50717

Study type

Interventional

Funder types

Industry

Identifiers

NCT03567291

2016-000630-22 (EudraCT Number)

TV50717-CNS-30047

Details and patient eligibility

About

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.

Full 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]).

Enrollment

228 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

228 participants in 3 patient groups, including a placebo group

TEV-50717- Part A

Experimental group

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.

Treatment:

Drug: TEV-50717

TEV-50717- Part B RW

Experimental group

Description:

TEV-50717 is administered during Part B Randomized Drug Withdrawal (RW) 2-week period.

Treatment:

Drug: TEV-50717

Placebo- Part B RW

Placebo Comparator group

Description:

Placebo is administered during Part B Randomized Drug Withdrawal (RW) 2-week period only.