evaluation of safety and tolerability of long-term tev-50717 (deutetrabenazine) for treatment of tourette syndrome in children and adolescents

Conditions: Tourette Syndrome

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.

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 \[phase 3\]).

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

Keywords: adolescents children