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
Neurocrine Biosciences
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 ass…
Interventions
- DrugNBI-1065890
Oral administration
- DrugPlacebo
Oral administration
Locations (6)
- Neurocrine Clinical SiteChino, California
- Neurocrine Clinical SiteTorrance, California
- Neurocrine Clinical SiteHialeah, Florida
- Neurocrine Clinical SiteMiami, Florida
- Neurocrine Clinical SiteTampa, Florida
- Neurocrine Clinical SiteLincoln, Nebraska