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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Neurocrine Clinical Site
RECRUITING
Bryant
California
Neurocrine Clinical Site
RECRUITING
Orange
Florida
Neurocrine Clinical Site
RECRUITING
Bonita Springs
Neurocrine Clinical Site
RECRUITING
Hialeah
Neurocrine Clinical Site
RECRUITING
Miami
Contact Information
Primary
Neurocrine Medical Information Call Center
medinfo@neurocrine.com
1-877-641-3461
Time Frame
Start Date: 2025-08-29
Estimated Completion Date: 2027-04
Participants
Target number of participants: 50
Treatments
Experimental: Valbenazine
Valbenazine administered once daily for 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Neurocrine Biosciences