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

Sponsor

Neurocrine Biosciences (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05545111

Collaborator

(none)

213

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: NBI-1117568 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

213 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Neurocrine Biosciences

Investigators

Study Director: Clinical Development Lead, Neurocrine Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neurocrine Biosciences

ClinicalTrials.gov Identifier:

NCT05545111

Other Study ID Numbers:

NBI-1117568-SCZ2028

First Posted:

Sep 19, 2022

Last Update Posted:

Sep 19, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Neurocrine Biosciences

schizophrenia

NBI-1117568

muscarinic

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Sep 19, 2022