A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome

CompletadoFase 3ClinicalTrials.gov

ID: NCT03571256Tipo: INTERVENTIONALInicio: 31 de may de 2018Fin estimado: 9 de dic de 2019

Traducción no disponible, mostrando original

Resumen

Standard placebo-controlled, double-blind study design (TEV-50717 \[low dose and high dose\] vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in a statistically significant effect on the tics in participants with TS.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 16 YearsSexo: ALL

Criterios de inclusión

Participant weighs at least 44 pounds (20 kg) at baseline.
Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the participant's active tics are causing distress or impairment.
Participant has a TTS of 20 or higher on the YGTSS at screening and baseline.
Participant is able to swallow study medication whole.
Additional criteria apply, please contact the investigator for more information

Criterios de exclusión

Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
The participant 's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
Participant has clinically significant depression at screening or baseline.
Participant has a history of suicidal intent or related behaviors within 2 years of screening
Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
Participant has a first-degree relative who has completed suicide.
Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
Participant has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
Participant has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics.
Participant has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
Participant has participated in an investigational drug or device study and received investigational medicinal product (IMP)/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
Participant is a pregnant or lactating female, or plans to be pregnant during the study.
Additional criteria apply, please contact the investigator for more information

Intervenciones

drug

TEV-50717

6-, 9-, 12-, 15-, and 18 mg oral tablets

drug

Placebo

Placebo matched to TEV-50717 tablets will be taken BID.

Ubicaciones

Teva Investigational Site 060-1407

Buenos Aires, Argentina

Teva Investigational Site 060-1401

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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