An Open-Label, Long-Term Safety Study Including a Double-... | EligiMed

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

TerminadoFase 3ClinicalTrials.gov

ID: NCT03567291RENIS: IS002178Tipo: INTERVENTIONALInicio: 25 de may de 2018Fin estimado: 15 de may de 2020

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Resumen

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.

Descripción detallada

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 \[Phase 3\]).

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

TEV-50717

6, 9, and 12 mg oral tablets

drug

Placebo

Placebo comparator

Ubicaciones

Teva Investigational Site 060-1407

Buenos Aires, Argentina

Teva Investigational Site 060-1402

Buenos Aires, Argentina

Teva Investigational Site 060-1403

La Plata, Argentina

Teva Investigational Site 060-1404

Mendoza, Argentina

Patrocinadores

PrincipalTeva Branded Pharmaceutical Products R&D, Inc.

ColaboradorNuvelution TS Pharma, Inc.

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