A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Overview
- Phase
- Phase 2
- Intervention
- NBI-1117568
- Conditions
- Schizophrenia
- Sponsor
- Neurocrine Biosciences
- Enrollment
- 213
- Locations
- 2
- Primary Endpoint
- Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Completed informed consent.
- •Subject has a primary diagnosis of schizophrenia.
- •The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
- •Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
- •Subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
Exclusion Criteria
- •An unstable medical condition, chronic disease, or malignancy.
- •Considered by the investigator to be at imminent risk of suicide or injury to self or others.
- •Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
- •Positive alcohol test or drug screen for disallowed substances.
- •Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.
Arms & Interventions
Dose Level A
Participant administered Dose Level A (6 weeks)
Intervention: NBI-1117568
Dose Level B
Participant administered Dose Level B (6 weeks)
Intervention: NBI-1117568
Dose Level C
Participant administered Dose Level C (6 weeks)
Intervention: NBI-1117568
Dose Level D
Participant administered Dose Level D (6 weeks)
Intervention: NBI-1117568
Placebo Schedule
Participant administered placebo (6 weeks)
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
Time Frame: Baseline and Week 6
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.