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

• Status: Completed
• Trial end date: 2019-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Collaborator: Nuvelution TS Pharma, Inc.
• Treatments: Tetrabenazine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.