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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545111
• Other study ID #: NBI-1117568-SCZ2028
• Status: Recruiting
• Phase: Phase 2
• Start date: October 4, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Neurocrine Biosciences
• Contact: Neurocrine Medical Information Call Center
• Phone: 877-641-3461
• Email: medinfo[@]neurocrine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• NBI-1117568
Active treatment with orally administered NBI-1117568
• Placebo
Placebo matching NBI-1117568

Locations

Country	Name	City	State
United States	Neurocrine Clinical Site	Austin	Texas
United States	Neurocrine Clinical Site	Berlin	New Jersey
United States	Neurocrine Clinical Site	DeSoto	Texas
United States	Neurocrine Clinical Site	Gaithersburg	Maryland
United States	Neurocrine Clinical Site	Lemon Grove	California
United States	Neurocrine Clinical Site	Little Rock	Arkansas
United States	Neurocrine Clinical Site	Miami Lakes	Florida
United States	Neurocrine Clinical Site	North Canton	Ohio
United States	Neurocrine Clinical Site	Oakland Park	Florida
United States	Neurocrine Clinical Site	Pico Rivera	California
United States	Neurocrine Clinical Site	Richardson	Texas
United States	Neurocrine Clinical Site	Rogers	Arkansas
United States	Neurocrine Clinical site	Saint Louis	Missouri
United States	Neurocrine Clinical Site	San Diego	California
United States	Neurocrine Clinical Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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