Phase 3 N=158 Randomized Quadruple-blind Treatment

A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)

Tourette Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03571256 ↗

Enrolled (actual)

158

Serious AEs

0.6%

Results posted

Jun 2020

Primary outcome: Primary: Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants — -7.8; -7.0 units on a scale — p=0.600

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: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-7.8; -7.0	0.600
SECONDARY Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.8; -0.6	—
SECONDARY Change From Baseline in the TTS of the YGTSS at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-5.9; -7.0	—
SECONDARY Change From Baseline in the TS-CGI Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.6; -0.6	—
SECONDARY Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.8; -0.7	—
SECONDARY Change From Baseline in the TS-PGII Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.7; -0.7	—
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 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-10.3; -9.0	—
SECONDARY Change From Baseline in the C&A-GTS-QOL ADL Subscale Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-10.0; -9.0	—
SECONDARY Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version and Self-reported Version) Total Score at Week 9	-1.2; -3.8; -0.8; -2.0; -2.6; -0.4	—
SECONDARY Number of Participants at Baseline and Week 9 With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)	0; 0; 2; 0; 0; 0	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03571256). 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.