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 (5) 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
Bulgaria
Neurocrine Clinical Site
RECRUITING
Kazanlak
Neurocrine Clinical Site
RECRUITING
Pazardzhik
Neurocrine Clinical Site
RECRUITING
Targovishte
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