NCT07105111RecruitingPhase 4
A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Neurocrine Biosciences23 sites in 1 country100 target enrollmentStarted: August 29, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences
- Enrollment
- 100
- Locations
- 23
- Primary Endpoint
- Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24
Study Overview
Brief Summary
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
- •Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening
Exclusion Criteria
- •Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD
- •Diagnosis of moderate or severe substance use disorder in the last 6 months
- •History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment
Arms & Interventions
Valbenazine
Experimental
Valbenazine administered once daily for 24 weeks.
Intervention: Valbenazine (Drug)
Outcomes
Primary Outcomes
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24
Time Frame: Baseline, Week 24
Secondary Outcomes
- Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24(Baseline, Week 24)
- Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24(Baseline, Week 24)
- Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24(Baseline, Week 24)
Investigators
Study Sites (23)
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