A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 18 to 55 years of age
• Primary diagnosis of schizophrenia ≥1 year before screening.
• Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization.
• Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse.
Locations
Other Locations
United Kingdom
Neurocrine Clinical Site
RECRUITING
London
Neurocrine Clinical Site
RECRUITING
Oxford
Contact Information
Primary
Neurocrine Medical Information Call Center
medinfo@neurocrine.com
1-877-641-3461
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2027-08
Participants
Target number of participants: 120
Treatments
Experimental: NBI-1117570: Lower-dose
Participants will receive a lower-dose of NBI-1117570.
Experimental: NBI-1117570: Higher-dose
Participants will receive a higher-dose of NBI-1117570.
Placebo_comparator: Placebo
Participants will receive placebo matched to NBI-1117570.
Related Therapeutic Areas
Sponsors
Leads: Neurocrine Biosciences