Status:
COMPLETED
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborating Sponsors:
Nuvelution TS Pharma, Inc.
Conditions:
Tourette Syndrome
Eligibility:
All Genders
6-16 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- Participant is 6 to 16 years of age, inclusive.
- 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
- Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
- 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.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2019
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03452943
Start Date
February 5 2018
End Date
November 12 2019
Last Update
November 9 2021
Active Locations (42)
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1
Teva Investigational Site 046-0104
Dothan, Alabama, United States, 36303
2
Teva Investigational Site 046-0117
Sun City, Arizona, United States, 85351
3
Teva Investigational Site 046-0107
Rogers, Arkansas, United States, 72758
4
Teva Investigational Site 046-0126
Anaheim, California, United States, 92805