Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
NCT ID: NCT03452943
Last Updated: 2021-11-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
119 participants
INTERVENTIONAL
2018-02-05
2019-11-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TEV-50717
TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks
TEV-50717
6, 9, 12, 15, and 18 mg oral tablets
Placebo
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
Placebo
Placebo matched to TEV-50717 BID for a total of 12 weeks
Placebo
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TEV-50717
6, 9, 12, 15, and 18 mg oral tablets
Placebo
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participant weighs at least 44 pounds (20 kilograms \[kg\]).
* The participant's active tics are causing distress or impairment.
* Participant is able to swallow study medication whole.
* Participant 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
* Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic 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 received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
* Participant has an unstable or serious medical illness at screening or baseline.
* Participant is pregnant or breastfeeding.
* Additional criteria apply, please contact the investigator for more information.
6 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nuvelution TS Pharma, Inc.
INDUSTRY
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Teva Investigational Site 046-0104
Dothan, Alabama, United States
Teva Investigational Site 046-0117
Sun City, Arizona, United States
Teva Investigational Site 046-0107
Rogers, Arkansas, United States
Teva Investigational Site 046-0126
Anaheim, California, United States
Teva Investigational Site 046-0101
Sacramento, California, United States
Teva Investigational Site 046-0111
San Diego, California, United States
Teva Investigational Site 046-0130
Santa Ana, California, United States
Teva Investigational Site 046-0132
Miami, Florida, United States
Teva Investigational Site 046-0115
Orlando, Florida, United States
Teva Investigational Site 046-0114
St. Petersburg, Florida, United States
Teva Investigational Site 046-0116
Atlanta, Georgia, United States
Teva Investigational Site 046-0133
Naperville, Illinois, United States
Teva Investigational Site 046-0128
Boston, Massachusetts, United States
Teva Investigational Site 046-0110
Saint Charles, Missouri, United States
Teva Investigational Site 046-0134
Lincoln, Nebraska, United States
Teva Investigational Site 046-0109
Voorhees Township, New Jersey, United States
Teva Investigational Site 046-0124
New York, New York, United States
Teva Investigational Site 046-0102
Rochester, New York, United States
Teva Investigational Site 046-0112
Rochester, New York, United States
Teva Investigational Site 046-0125
Raleigh, North Carolina, United States
Teva Investigational Site 046-0106
Oklahoma City, Oklahoma, United States
Teva Investigational Site 046-0113
Dallas, Texas, United States
Teva Investigational Site 046-0108
Houston, Texas, United States
Teva Investigational Site 046-0103
Houston, Texas, United States
Teva Investigational Site 046-0120
San Antonio, Texas, United States
Teva Investigational Site 046-0105
Orem, Utah, United States
Teva Investigational Site 046-0118
Petersburg, Virginia, United States
Teva Investigational Site 046-0201
Ajax, Ontario, Canada
Teva Investigational Site 046-0202
Ottawa, Ontario, Canada
Teva Investigational Site 046-0302
Herlev, , Denmark
Teva Investigational Site 046-0301
Odense, , Denmark
Teva Investigational Site 046-0702
Stavropol, , Russia
Teva Investigational Site 046-0704
Tomsk, , Russia
Teva Investigational Site 046-0703
Voronezh, , Russia
Teva Investigational Site 046-1702
Belgrade, , Serbia
Teva Investigational Site 046-1703
Belgrade, , Serbia
Teva Investigational Site 046-1701
Novi Sad, , Serbia
Teva Investigational Site 046-0604
Barcelona, , Spain
Teva Investigational Site 046-0605
Madrid, , Spain
Teva Investigational Site 046-0602
Madrid, , Spain
Teva Investigational Site 046-0603
Málaga, , Spain
Teva Investigational Site 046-0601
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jankovic J, Coffey B, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander J, Barkay H, Harary E. Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128204. doi: 10.1001/jamanetworkopen.2021.28204.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-000622-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TV50717-CNS-30046
Identifier Type: -
Identifier Source: org_study_id