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

May 18, 2026 updated by: Neurocrine Biosciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Recruiting
        • Neurocrine Clinical Site
    • California
      • Chino, California, United States, 91710
        • Recruiting
        • Neurocrine Clinical Site
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Neurocrine Clinical Site
      • Long Beach, California, United States, 90807
        • Recruiting
        • Neurocrine Clinical Site
      • Temecula, California, United States, 92591
        • Recruiting
        • Neurocrine Clinical Site
      • Torrance, California, United States, 90501
        • Recruiting
        • Neurocrine Clinical Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Neurocrine Clinical Site
      • Bonita Springs, Florida, United States, 34134
        • Recruiting
        • Neurocrine Clinical Site
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Neurocrine Clinical Site
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Neurocrine Clinical Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Neurocrine Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Neurocrine Clinical Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • Neurocrine Clinical Site
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least 3 months prior to screening.
  • Medically confirmed diagnosis of neuroleptic-induced TD as defined in the DSM-5 for at least 3 months prior to screening.
  • Moderate or severe TD (AIMS Item 8, severity of abnormal movement overall) as assessed by a blinded, external AIMS video reviewer using a video recording of the participant's AIMS assessment administered at the clinical site by a blinded, certified site AIMS rater. The AIMS dyskinesia total score (sum of Items 1 to 7) must be ≥6 as assessed by the blinded, external AIMS video reviewer.

Key Exclusion Criteria:

  • Comorbid parkinsonism (drug-induced or otherwise) or more than a minimal level of extrapyramidal signs/symptoms, as documented by a score on the Modified Simpson-Angus Scale (mSAS) (excluding Items 8 and 10) >6 at screening or Day -1 (baseline) or a score >3 in any one item (excluding Items 8 and 10).
  • Barnes Akathisia Rating Scale (BARS) global clinical assessment score ≥2 at screening or Day -1.
  • Brief Psychiatric Rating Scale (BPRS) total score ≥50 at screening or Day -1.
  • Hospitalized for schizophrenia, schizoaffective disorder, bipolar disorder, or MDD within 6 months of screening.
  • Participant has an unstable medical condition or unstable chronic disease.
  • Any known history of neuroleptic malignant syndrome (NMS).

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBI-1065890
Participants will receive NBI-1065890.
Drug: NBI-1065890
Oral administration
Placebo Comparator: Placebo
Participants will receive placebo matching NBI-1065890.
Drug: Placebo
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment
Time Frame: Baseline and Week 8
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Are a Clinical Global Impression - Improvement (CGI-I) Responder 1 at Week 8
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-1065890-TD2033
  • 2025-524104-30-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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