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

Phase 2

Recruiting

• Conditions: Schizophrenia
• Interventions: Drug: NBI-1117568; Drug: Placebo

• Registration Number: NCT05545111
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Study Start: 2022-10-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 213

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Level A	NBI-1117568	Participant administered Dose Level A (6 weeks)
Placebo Schedule	Placebo	Participant administered placebo (6 weeks)
Dose Level D	NBI-1117568	Participant administered Dose Level D (6 weeks)
Dose Level C	NBI-1117568	Participant administered Dose Level C (6 weeks)
Dose Level B	NBI-1117568	Participant administered Dose Level B (6 weeks)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Neurocrine Clinical site; 🇺🇸 Saint Louis, Missouri, United States

Neurocrine Clinical Site; 🇺🇸 Richardson, Texas, United States