Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Study Overview
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Brief Summary
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This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Detailed Description
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This study was terminated after 60 weeks due to the commercial availability of valbenazine.

Official Title
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Open-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Conditions
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Tardive Dyskinesia

Intervention / Treatment
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* Drug: Valbenazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study. Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses. Be in general good health. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol. Exclusion Criteria: Have an active, clinically significant unstable medical condition within 1 month prior to screening. Have a known history of substance dependence, substance (drug) or alcohol abuse. Have a significant risk of suicidal or violent behavior. Have a known history of neuroleptic malignant syndrome. Have a known history of long QT syndrome or cardiac arrhythmia. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed). Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than valbenazine) during the study. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline. Have an allergy, hypersensitivity, or intolerance to tetrabenazine. Are currently pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Valbenazine<br>Fixed dose of valbenazine administered once daily for up to 72 weeks | Drug: Valbenazine<br> <br> * Other names: NBI-98854;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Monitored for Long-term Safety of Valbenazine | Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. | 60 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= Normal, not at all ill to 7= Among the most extremely ill patient). A clinical response was defined as a CGI-TD-S score equal to 1 or 2. | Baseline and Weeks 12, 24, 36, 48, and 60 | 
| Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ) | Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to 1 or 2. | Baseline and Weeks 12, 24, 36, 48, and 60 |