A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS) (ARTISTS2)

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Tourette Syndrome

Treatments: Drug: Placebo; Drug: TEV-50717

Study type: Interventional

Funder types: Industry

Identifiers

NCT03571256

2017-002976-24 (EudraCT Number)

TV50717-CNS-30060

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 3 patient groups, including a placebo group

TEV-50717 High-Dose

Experimental group

Description:

TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks

Treatment:

Drug: TEV-50717

Drug: Placebo

TEV-50717 Low-Dose

Experimental group

Description:

TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks

Treatment:

Drug: TEV-50717

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo matched to TEV-50717 for a total of 8 weeks

Treatment:

Drug: Placebo