Phase 3 N=119 Randomized Quadruple-blind Treatment

Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

Tourette Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03452943 ↗

Enrolled (actual)

119

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Change From Baseline in the TTS of the YGTSS at Week 12 — -9.1; -8.4 units on a scale — p=0.692

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TEV-50717 (Drug); Placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the TTS of the YGTSS at Week 12	-9.1; -8.4	0.692
SECONDARY Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12	-0.7; -0.7	—
SECONDARY Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12	-0.7; -0.4	—
SECONDARY Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score at Week 12	-9.9; -8.8	—
SECONDARY Percentage of Participants With Adverse Events	65.5; 55.9; 50.0; 20.3; 0; 0	—

Summary

This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.

Eligibility Criteria

Inclusion Criteria

Participant is 6 to 16 years of age, inclusive.
Participant weighs at least 44 pounds (20 kilograms [kg]).
The participant's active tics are causing distress or impairment.
Participant is able to swallow study medication whole.
Participant 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

Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic 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 received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
Participant has an unstable or serious medical illness at screening or baseline.
Participant is pregnant or breastfeeding.
Additional criteria apply, please contact the investigator for more information.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03452943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.