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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
Active treatment with orally administered NBI-1117568
Placebo matching NBI-1117568
Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
Rogers, Arkansas, United States
Neurocrine Clinical Site
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.
Time frame: Baseline and Week 6
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Lemon Grove, California, United States
Neurocrine Clinical Site
Pico Rivera, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Miami Lakes, Florida, United States
Neurocrine Clinical Site
Oakland Park, Florida, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, United States
Neurocrine Clinical site
St Louis, Missouri, United States
...and 5 more locations