NCT07365462

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
10mo left

Started Jan 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

January 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 23, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

January 22, 2026

Last Update Submit

April 21, 2026

Conditions

Tardive Dyskinesia

Keywords

Tardive DyskinesiaNBI-1065890

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and Week 8

Secondary Outcomes (1)

  • Percentage of Participants Who Are a Clinical Global Impression - Improvement (CGI-I) Responder 1 at Week 8

    Week 8

Study Arms (2)

NBI-1065890

EXPERIMENTAL

Participants will receive NBI-1065890.

Drug: NBI-1065890

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching NBI-1065890.

Drug: Placebo

Interventions

NBI-1065890DRUG

Oral administration

NBI-1065890
PlaceboDRUG

Oral administration

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Neurocrine Clinical Site

Chino, California, 91710, United States

RECRUITING

Neurocrine Clinical Site

Torrance, California, 90501, United States

RECRUITING

Neurocrine Clinical Site

Hialeah, Florida, 33012, United States

RECRUITING

Neurocrine Clinical Site

Miami, Florida, 33176, United States

RECRUITING

Neurocrine Clinical Site

Tampa, Florida, 33629, United States

RECRUITING

Neurocrine Clinical Site

Lincoln, Nebraska, 68526, United States

RECRUITING

MeSH Terms

Conditions

Tardive Dyskinesia

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Development Lead

    Neurocrine Biosciences

    STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 26, 2026

Study Start

January 23, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(6)