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

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ClinicalTrials.gov Identifier: NCT03571256
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Nuvelution TS Pharma, Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief 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 IMP treatment results in a statistically significant effect on the tics in patients with TS.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Drug: deutetrabenazine Low Drug: deutetrabenazine High Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : May 4, 2020
Estimated Study Completion Date : May 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TEV-50717 [high]
The target dose for each patient receiving TEV-50717 will be based on the group to which they are randomized, body weight at baseline, and cytochrome P450 2D6 (CYP2D6) impairment status.
Drug: deutetrabenazine High
6-, 9-, 12-, 15-, and 18-mg tablets
Other Name: TEV-50717, SD-809, AUSTEDO

Experimental: TEV-50717 [low]
The target dose for each patient receiving TEV-50717 will be based on the group to which they are randomized, body weight at baseline, and cytochrome P450 2D6 (CYP2D6) impairment status.
Drug: deutetrabenazine Low
6-, 9-, 12-, 15-, and 18-mg tablets
Other Name: TEV-50717, SD-809, AUSTEDO

Placebo Comparator: Placebo
Placebo Comparator
Drug: deutetrabenazine Low
6-, 9-, 12-, 15-, and 18-mg tablets
Other Name: TEV-50717, SD-809, AUSTEDO

Drug: Placebo
Matching Placebo
Other Name: Matching Placebo




Primary Outcome Measures :
  1. Change in the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) - High dose [ Time Frame: Baseline - Week 8 ]
    The YGTSS ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.


Secondary Outcome Measures :
  1. Change in the Tourette Syndrome-Clinical Global Impression (TS-CGI) score - High dose [ Time Frame: Baseline - Week 8 ]
  2. Change in TTS of YGTSS - Low dose [ Time Frame: Baseline - Week 8 ]
  3. Change in the TS-CGI score - Low dose [ Time Frame: Baseline - Week 8 ]
  4. Change in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) score - High dose [ Time Frame: Baseline - Week 8 ]
  5. Change in TS-PGII- Low dose [ Time Frame: Baseline - Week 8 ]
  6. Change in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life- scale (C&A-GTS-QOL) - High dose [ Time Frame: Baseline - Week 8 ]
  7. Change in C&A-GTS-QOL ADL - Low dose [ Time Frame: Baseline - Week 8 ]


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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 clinically significant depression at screening or baseline.
  • 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 a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
  • 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 within 4 weeks of the screening visit for reduction of tics.
  • Patient has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
  • Patient has participated in an investigational drug or device study and received IMP/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
  • Patient is a pregnant or lactating female, or plans to be pregnant during the study.
  • -Additional criteria apply, please contact the investigator for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571256


Contacts
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Contact: Teva U.S. Medical Information 1-888-743-9887 USMedInfo@tevapharm.com

  Show 40 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Nuvelution TS Pharma, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT03571256     History of Changes
Other Study ID Numbers: TV50717-CNS-30060
2017-002976-24 ( EudraCT Number )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs