Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome

Study Overview
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Brief Summary
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This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.

Official Title
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Open-Label Rollover Study for Continuing NBI-98854 Administration for the Treatment of Pediatric Subjects With Tourette Syndrome

Conditions
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Tourette Syndrome

Intervention / Treatment
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* Drug: NBI-98854


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a clinical diagnosis of Tourette Syndrome (TS) Have participated in the NBI-98854-TS2004 or NBI 98854-TS2005 Phase 2 studies If using maintenance medication(s) for TS and/or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses Be in good general health Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study Exclusion Criteria: Have an active, clinically significant unstable medical condition within 1 month before screening Have a known history of long QT syndrome or cardiac arrhythmia Have a known history of neuroleptic malignant syndrome Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors Have a blood loss ≥250 mL or donated blood within 56 days, or donated plasma within 7 days, before the start of the study Have a known history of substance dependence, substance (drug) or alcohol abuse within 3 months before the start of the study Have a significant risk of suicidal or violent behavior Have received an investigational drug within 30 days before the start of the study or plan to use an investigational drug (other than NBI-98854) during the study Are currently participating in another NBI-98854 clinical study Are pregnant (for females)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBI-98854<br>NBI-98854 administered once daily for up to 96 weeks | Drug: NBI-98854<br>* vesicular monoamine transporter 2 (VMAT2) inhibitor<br>* Other names: Valbenazine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing. | Up to 16 Weeks |