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
Neurocrine Biosciences
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological…
Interventions
- DrugNBI-1117568
Oral capsules
- DrugPlacebo
Oral capsules
Locations (17)
- Neurocrine Clinical SiteGarden Grove, California
- Neurocrine Clinical SiteLa Habra, California
- Neurocrine Clinical SiteLemon Grove, California
- Neurocrine Clinical SiteOceanside, California
- Neurocrine Clinical SiteWest Hills, California
- Neurocrine Clinical SiteHollywood, Florida