Recruiting

Phase 2

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

Sponsor:

Neurocrine Biosciences

Code:

NCT07365462

Conditions

Tardive Dyskinesia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NBI-1065890

Placebo

Study Details

Brief summary:

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

Tardive Dyskinesia

Study ID

NCT07365462

Start date

Feb 6, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1065890

Participants will receive NBI-1065890.

placebo comparator: Placebo

Participants will receive placebo matching NBI-1065890.

Interventions

NBI-1065890

Oral administration

Placebo

Oral administration

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461 medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Bryant, Arkansas, United States, 72022

Neurocrine Clinical Site

Recruiting

Chino, California, United States, 91710

Neurocrine Clinical Site

Recruiting

Fountain Valley, California, United States, 92708

Neurocrine Clinical Site

Recruiting

Huntington Beach, California, United States, 92648

Neurocrine Clinical Site

Recruiting

Long Beach, California, United States, 90807

Neurocrine Clinical Site

Recruiting

Temecula, California, United States, 92591

Neurocrine Clinical Site

Recruiting

Torrance, California, United States, 90501

Neurocrine Clinical Site

Recruiting

Boca Raton, Florida, United States, 33486

Neurocrine Clinical Site

Recruiting

Bonita Springs, Florida, United States, 34134

Neurocrine Clinical Site

Recruiting

Hialeah, Florida, United States, 33012

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33176

Neurocrine Clinical Site

Recruiting

Orange City, Florida, United States, 32763

Neurocrine Clinical Site

Recruiting

Tampa, Florida, United States, 33629

Neurocrine Clinical Site

Recruiting

Marietta, Georgia, United States, 30060

Neurocrine Clinical Site

Recruiting

Lincoln, Nebraska, United States, 68526

Neurocrine Clinical Site

Recruiting

Beachwood, Ohio, United States, 44122

Neurocrine Clinical Site

Recruiting

Fort Worth, Texas, United States, 76104

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

Tardive Dyskinesia
NBI-1065890

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-06-23.