A 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
Neurocrine Biosciences
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568. * Participant h…
Interventions
- DrugNBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
- DrugPlacebo
Placebo will be administered per schedule specified in the arm description.
Locations (21)
- Neurocrine Clinical SiteBryant, Arkansas
- Neurocrine Clinical SiteLittle Rock, Arkansas
- Neurocrine Clinical SiteAnaheim, California
- Neurocrine Clinical SitePico Rivera, California
- Neurocrine Clinical SiteSan Diego, California
- Neurocrine Clinical SiteSherman Oaks, California