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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Neurocrine Clinical Site
RECRUITING
Bryant
California
Neurocrine Clinical Site
RECRUITING
Chino
Neurocrine Clinical Site
RECRUITING
Huntington Beach
Neurocrine Clinical Site
RECRUITING
Long Beach
Neurocrine Clinical Site
RECRUITING
Temecula
Neurocrine Clinical Site
RECRUITING
Torrance
Florida
Neurocrine Clinical Site
RECRUITING
Boca Raton
Neurocrine Clinical Site
RECRUITING
Bonita Springs
Neurocrine Clinical Site
RECRUITING
Hialeah
Neurocrine Clinical Site
RECRUITING
Miami
Neurocrine Clinical Site
RECRUITING
Orange City
Neurocrine Clinical Site
RECRUITING
Tampa
Georgia
Neurocrine Clinical Site
RECRUITING
Marietta
Nebraska
Neurocrine Clinical Site
RECRUITING
Lincoln
Ohio
Neurocrine Clinical Site
RECRUITING
Beachwood
Texas
Neurocrine Clinical Site
RECRUITING
Fort Worth
Neurocrine Clinical Site
RECRUITING
Houston
Contact Information
Primary
Neurocrine Medical Information Call Center
medinfo@neurocrine.com
1-877-641-3461
Time Frame
Start Date:2026-02-06
Estimated Completion Date:2027-03
Participants
Target number of participants:100
Treatments
Experimental: NBI-1065890
Participants will receive NBI-1065890.
Placebo_comparator: Placebo
Participants will receive placebo matching NBI-1065890.