Schizophrenia
Conditions
Keywords
schizophrenia, NBI-1117568, muscarinic
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.
Interventions
DRUGNBI-1117568
Active treatment with orally administered NBI-1117568
DRUGPlacebo
Placebo matching NBI-1117568
Sponsors
Neurocrine Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed