Clinical trial NCT05545111: Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia
NBI-1117568
muscarinic
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2022-09-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Rogers
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Lemon Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Pico Rivera
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: Torrance
country: United States
facility: Neurocrine Clinical Site
state: California
city: Miami Lakes
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Oakland Park
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Gaithersburg
country: United States
facility: Neurocrine Clinical Site
state: Maryland
city: Saint Louis
country: United States
facility: Neurocrine Clinical site
state: Missouri
city: Berlin
country: United States
facility: Neurocrine Clinical Site
state: New Jersey
city: North Canton
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Austin
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: DeSoto
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Richardson
country: United States
facility: Neurocrine Clinical Site
state: Texas
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: