Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: NBI-1117568
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key 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. Key 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Level A<br>Participant administered Dose Level A (6 weeks) | Drug: NBI-1117568<br>* Active treatment with orally administered NBI-1117568<br>|
| Experimental: Dose Level B<br>Participant administered Dose Level B (6 weeks) | Drug: NBI-1117568<br>* Active treatment with orally administered NBI-1117568<br>|
| Experimental: Dose Level C<br>Participant administered Dose Level C (6 weeks) | Drug: NBI-1117568<br>* Active treatment with orally administered NBI-1117568<br>|
| Experimental: Dose Level D<br>Participant administered Dose Level D (6 weeks) | Drug: NBI-1117568<br>* Active treatment with orally administered NBI-1117568<br>|
| Placebo Comparator: Placebo Schedule<br>Participant administered placebo (6 weeks) | Drug: Placebo<br>* Placebo matching NBI-1117568<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at 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. | Baseline and Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, NBI-1117568, muscarinic