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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Tourette Syndrome

Treatments: Drug: Placebo; Drug: TEV-50717

Study type: Interventional

Funder types: Industry

Identifiers

NCT03452943

TV50717-CNS-30046

2016-000622-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 2 patient groups, including a placebo group

TEV-50717

Experimental group

Description:

TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks

Treatment:

Drug: Placebo

Drug: TEV-50717

Placebo

Placebo Comparator group

Description:

Placebo matched to TEV-50717 BID for a total of 12 weeks

Treatment:

Drug: Placebo