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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1065890 in Adult Participants With Tardive Dyskinesia
Led by Neurocrine Biosciences · Updated on 2026-05-19
100
Participants Needed
17
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the drug NBI-1065890 compared with a placebo in treating adults with tardive dyskinesia (TD), a condition involving involuntary movements. This Phase 2 trial aims to assess the safety, tolerability, and impact of NBI-1065890 on TD symptoms in adults aged 18 to 75 years. Participants must have a medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder, along with neuroleptic-induced TD. In this randomized, double-blind study, participants will receive either NBI-1065890 or a matching placebo by mouth. The trial includes two groups: one taking the experimental drug and the other taking placebo. The study is designed to compare changes in abnormal involuntary movements over an 8-week period, with treatments administered during this time. The study uses blinded assessments to measure the severity of dyskinesia. Participants will undergo evaluations including video assessments of involuntary movements at the start and after 8 weeks of treatment. Researchers will measure changes in the Abnormal Involuntary Movement Scale (AIMS) total score and assess clinical improvement using standard rating scales. Safety and tolerability will be closely monitored. The total participation time includes screening and an 8-week treatment period, with follow-up assessments to capture treatment effects and side effects.
CONDITIONS
Brief 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 (MDD) as defined in DSM-5 for at least 3 months prior to screening
- Medically confirmed diagnosis of neuroleptic-induced tardive dyskinesia as defined in DSM-5 for at least 3 months prior to screening
- Moderate or severe tardive dyskinesia with an AIMS dyskinesia total score of 6 or higher, assessed by a blinded external AIMS video reviewer
- Age between 18 and 75 years
You will not qualify if you...
- Comorbid parkinsonism or more than minimal extrapyramidal signs, indicated by a Modified Simpson-Angus Scale (mSAS) score above 6 (excluding Items 8 and 10) or above 3 on any single item (excluding Items 8 and 10) at screening or baseline
- Barnes Akathisia Rating Scale (BARS) global clinical assessment score 2 or higher at screening or baseline
- Brief Psychiatric Rating Scale (BPRS) total score 50 or higher at screening or baseline
- Hospitalization for schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder within 6 months before screening
- Unstable medical condition or unstable chronic disease
- Known history of neuroleptic malignant syndrome (NMS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive either NBI-1065890 or placebo by oral administration to assess the efficacy, safety, and tolerability in treating tardive dyskinesia.
Visits at baseline and Week 8
Trial Site Locations
Total: 17 locations
1
Neurocrine Clinical Site
Bryant, Arkansas, United States, 72022
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2
Neurocrine Clinical Site
Chino, California, United States, 91710
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3
Neurocrine Clinical Site
Huntington Beach, California, United States, 92648
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4
Neurocrine Clinical Site
Long Beach, California, United States, 90807
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5
Neurocrine Clinical Site
Temecula, California, United States, 92591
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6
Neurocrine Clinical Site
Torrance, California, United States, 90501
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7
Neurocrine Clinical Site
Boca Raton, Florida, United States, 33486
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8
Neurocrine Clinical Site
Bonita Springs, Florida, United States, 34134
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9
Neurocrine Clinical Site
Hialeah, Florida, United States, 33012
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10
Neurocrine Clinical Site
Miami, Florida, United States, 33176
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11
Neurocrine Clinical Site
Orange City, Florida, United States, 32763
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12
Neurocrine Clinical Site
Tampa, Florida, United States, 33629
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13
Neurocrine Clinical Site
Marietta, Georgia, United States, 30060
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14
Neurocrine Clinical Site
Lincoln, Nebraska, United States, 68526
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15
Neurocrine Clinical Site
Beachwood, Ohio, United States, 44122
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16
Neurocrine Clinical Site
Fort Worth, Texas, United States, 76104
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17
Neurocrine Clinical Site
Houston, Texas, United States, 77030
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Research Team
N
Neurocrine Medical Information Call Center
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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