Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Purpose
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.
Condition
- Tardive Dyskinesia
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NBI-1065890 |
Participants will receive NBI-1065890. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matching NBI-1065890. |
|
Recruiting Locations
Neurocrine Clinical Site
Bryant, Arkansas 72022
Bryant, Arkansas 72022
Neurocrine Clinical Site
Chino, California 91710
Chino, California 91710
Neurocrine Clinical Site
Fountain Valley, California 92708
Fountain Valley, California 92708
Neurocrine Clinical Site
Huntington Beach, California 92648
Huntington Beach, California 92648
Neurocrine Clinical Site
Long Beach, California 90807
Long Beach, California 90807
Neurocrine Clinical Site
Temecula, California 92591
Temecula, California 92591
Neurocrine Clinical Site
Torrance, California 90501
Torrance, California 90501
Neurocrine Clinical Site
Boca Raton, Florida 33486
Boca Raton, Florida 33486
Neurocrine Clinical Site
Bonita Springs, Florida 34134
Bonita Springs, Florida 34134
Neurocrine Clinical Site
Hialeah, Florida 33012
Hialeah, Florida 33012
Neurocrine Clinical Site
Miami, Florida 33176
Miami, Florida 33176
Neurocrine Clinical Site
Orange City, Florida 32763
Orange City, Florida 32763
Neurocrine Clinical Site
Tampa, Florida 33629
Tampa, Florida 33629
Neurocrine Clinical Site
Marietta, Georgia 30060
Marietta, Georgia 30060
Neurocrine Clinical Site
Lincoln, Nebraska 68526
Lincoln, Nebraska 68526
Neurocrine Clinical Site
Beachwood, Ohio 44122
Beachwood, Ohio 44122
Neurocrine Clinical Site
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Neurocrine Clinical Site
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences