Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07365462

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia | DecenTrialz