Tardive Dyskinesia
Conditions
Keywords
Tardive Dyskinesia, NBI-1065890
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.
Interventions
DRUGNBI-1065890
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Neurocrine Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| 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 | Baseline and Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Are a Clinical Global Impression - Improvement (CGI-I) Responder 1 at Week 8 | Week 8 |
Countries
United States
Contacts
CONTACTNeurocrine Medical Information Call Center
STUDY_DIRECTORClinical Development Lead
Neurocrine Biosciences
Outcome results
None listed