A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Participant has a primary diagnosis of schizophrenia
• Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
• Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
• Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements
Locations
United States
California
Neurocrine Clinical Site
RECRUITING
Culver City
Neurocrine Clinical Site
RECRUITING
Garden Grove
Neurocrine Clinical Site
RECRUITING
Riverside
Georgia
Neurocrine Clinical Site
RECRUITING
Atlanta
Ohio
Neurocrine Clinical Site
RECRUITING
North Canton
Contact Information
Primary
Neurocrine Medical Information Call Center
medinfo@neurocrine.com
877-641-3461
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2027-11
Participants
Target number of participants: 284
Treatments
Experimental: NBI-1117568
Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
Placebo_comparator: Placebo
Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.
Related Therapeutic Areas
Sponsors
Leads: Neurocrine Biosciences