A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria.
• Participant had the initial diagnosis of schizophrenia ≥1 year before screening.
• Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.
Locations
United States
California
Neurocrine Clinical Site
RECRUITING
Garden Grove
Neurocrine Clinical Site
RECRUITING
La Habra
Neurocrine Clinical Site
RECRUITING
Lemon Grove
Neurocrine Clinical Site
RECRUITING
Oceanside
Neurocrine Clinical Site
RECRUITING
West Hills
Florida
Neurocrine Clinical Site
RECRUITING
Hollywood
Neurocrine Clinical Site
RECRUITING
Maitland
Neurocrine Clinical Site
RECRUITING
Miami
Neurocrine Clinical Site
RECRUITING
Tampa
Neurocrine Clinical Site
RECRUITING
West Palm Beach
Georgia
Neurocrine Clinical Site
RECRUITING
Atlanta
Massachusetts
Neurocrine Clinical Site
RECRUITING
Boston
Mississippi
Neurocrine Clinical Site
RECRUITING
Flowood
New York
Neurocrine Clinical Site
RECRUITING
Cedarhurst
Neurocrine Clinical Site
RECRUITING
New York
Neurocrine Clinical Site
RECRUITING
New York
Washington
Neurocrine Clinical Site
RECRUITING
Bellevue
Contact Information
Primary
Neurocrine Medical Information Call Center
medinfo@neurocrine.com
1-877-641-3461
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2029-07
Participants
Target number of participants: 560
Treatments
Experimental: NBI-1117568
All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period.
Placebo_comparator: Placebo
All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period.
Related Therapeutic Areas
Sponsors
Leads: Neurocrine Biosciences