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Alternatives for Reducing Tics in TS: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents. (ARTISTS1)

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ClinicalTrials.gov Identifier: NCT03452943
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Nuvelution TS Pharma, Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
TOURETTE SYNDROME Drug: TEV-50717 Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TEV-50717
TEV-50717 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period.
Drug: TEV-50717
6, 9, 12, 15, and 18 mg oral tablets
Other Name: deutetrabenazine

Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Placebo tablets taken twice daily for 12 weeks.




Primary Outcome Measures :
  1. Change in the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Baseline to week 12 ]
    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 [ Time Frame: Baseline to week 12 ]
  2. Change in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) score [ Time Frame: Baseline to week 12 ]
  3. Change in the Gilles de la Tourette Syndrome - Quality of Life (GTS-QOL) physical/activities of daily living (ADL) subscale [ Time Frame: Baseline to week 12 ]
  4. Percentage of Participants with Adverse Events [ Time Frame: 13 weeks ]


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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 is 6 to 16 years of age, inclusive
  • Patient weighs at least 44 pounds (20 kg)
  • The patient's active tics are causing distress or impairment
  • Patient is able to swallow study medication whole
  • Patient 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:

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

    • 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): NCT03452943


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

  Show 29 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Nuvelution TS Pharma, Inc.
Investigators
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT03452943     History of Changes
Other Study ID Numbers: TV50717-CNS-30046
2016-000622-19 ( EudraCT Number )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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

Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Tourette Syndrome
adolescents
children

Additional relevant MeSH terms:
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