Actively Recruiting
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Led by Neurocrine Biosciences · Updated on 2026-04-24
100
Participants Needed
6
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.
CONDITIONS
Official Title
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder for at least 3 months prior to screening
- Medically confirmed diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening
- Moderate or severe tardive dyskinesia as assessed by blinded external video review with an AIMS dyskinesia total score of 6 or higher
You will not qualify if you...
- Comorbid parkinsonism or more than minimal extrapyramidal symptoms with Modified Simpson-Angus Scale score above 6 or above 3 in any one item
- Barnes Akathisia Rating Scale global score of 2 or higher at screening or baseline
- Brief Psychiatric Rating Scale total score of 50 or higher at screening or baseline
- Hospitalization for schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder within 6 months prior to screening
- Unstable medical condition or unstable chronic disease
- Any known history of neuroleptic malignant syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Neurocrine Clinical Site
Chino, California, United States, 91710
Actively Recruiting
2
Neurocrine Clinical Site
Torrance, California, United States, 90501
Actively Recruiting
3
Neurocrine Clinical Site
Hialeah, Florida, United States, 33012
Actively Recruiting
4
Neurocrine Clinical Site
Miami, Florida, United States, 33176
Actively Recruiting
5
Neurocrine Clinical Site
Tampa, Florida, United States, 33629
Actively Recruiting
6
Neurocrine Clinical Site
Lincoln, Nebraska, United States, 68526
Actively Recruiting
Research Team
N
Neurocrine Medical Information Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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