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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level A | Experimental | Participant administered Dose Level A (6 weeks) |
|
| Dose Level B | Experimental | Participant administered Dose Level B (6 weeks) |
|
| Dose Level C | Experimental | Participant administered Dose Level C (6 weeks) |
|
| Dose Level D | Experimental | Participant administered Dose Level D (6 weeks) |
|
| Placebo Schedule | Placebo Comparator | Participant administered placebo (6 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-1117568 | Drug | Active treatment with orally administered NBI-1117568 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Lead | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Little Rock | Arkansas | 72211 | United States | ||
| Neurocrine Clinical Site |
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| Placebo | Drug | Placebo matching NBI-1117568 |
|
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Neurocrine Clinical Site | Lemon Grove | California | 91945 | United States |
| Neurocrine Clinical Site | Pico Rivera | California | 90660 | United States |
| Neurocrine Clinical Site | San Diego | California | 92123 | United States |
| Neurocrine Clinical Site | Torrance | California | 90502 | United States |
| Neurocrine Clinical Site | Miami Lakes | Florida | 33016 | United States |
| Neurocrine Clinical Site | Oakland Park | Florida | 33334 | United States |
| Neurocrine Clinical Site | Gaithersburg | Maryland | 20877 | United States |
| Neurocrine Clinical site | St Louis | Missouri | 63141 | United States |
| Neurocrine Clinical Site | Berlin | New Jersey | 08053 | United States |
| Neurocrine Clinical Site | North Canton | Ohio | 44720 | United States |
| Neurocrine Clinical Site | Austin | Texas | 78754 | United States |
| Neurocrine Clinical Site | DeSoto | Texas | 75115 | United States |
| Neurocrine Clinical Site | Richardson | Texas | 75080 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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