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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
TEV-50717 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period.
6, 9, 12, 15, and 18 mg oral tablets
Other Name: deutetrabenazine
Placebo Comparator: Placebo
Placebo tablets taken twice daily for 12 weeks.
- 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.
- Change in the Tourette Syndrome-Clinical Global Impression (TS-CGI) score [ Time Frame: Baseline to week 12 ]
- Change in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) score [ Time Frame: Baseline to week 12 ]
- 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 ]
- Percentage of Participants with Adverse Events [ Time Frame: 13 weeks ]
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
|Contact: Teva U.S. Medical Information||1-888-743-9887||USMedInfo@tevapharm.com|
Show 29 Study Locations
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|