A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depressive Disorder; Tardive Dyskinesia
• Interventions: Drug: Valbenazine

• Registration Number: NCT07105111
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-09-01
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Key

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valbenazine	Valbenazine	Valbenazine administered once daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
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