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The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI-1117568 | Experimental | Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-1117568 | Drug | NBI-1117568 will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5 | Baseline, Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5 | Baseline, Week 5 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-specified inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information Call Center | Contact | 877-641-3461 | medinfo@neurocrine.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Lead | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Recruiting | Bryant | Arkansas | 72022 | United States | |
| Neurocrine Clinical Site |
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| Placebo | Drug | Placebo will be administered per schedule specified in the arm description. |
|
| Recruiting |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Neurocrine Clinical Site | Recruiting | Anaheim | California | 92805 | United States |
| Neurocrine Clinical Site | Recruiting | Pico Rivera | California | 90660 | United States |
| Neurocrine Clinical Site | Recruiting | San Diego | California | 92123 | United States |
| Neurocrine Clinical Site | Recruiting | Sherman Oaks | California | 91403 | United States |
| Neurocrine Clinical Site | Recruiting | Torrance | California | 90504 | United States |
| Neurocrine Clinical Site | Recruiting | Hollywood | Florida | 33024 | United States |
| Neurocrine Clinical Site | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Neurocrine Clinical Site | Recruiting | Atlanta | Georgia | 30331 | United States |
| Neurocrine Clinical Site | Recruiting | Decatur | Georgia | 30030 | United States |
| Neurocrine Clinical Site | Recruiting | Snellville | Georgia | 30078 | United States |
| Neurocrine Clinical Site | Recruiting | Chicago | Illinois | 60640 | United States |
| Neurocrine Clinical Site | Recruiting | Gaithersburg | Maryland | 20877 | United States |
| Neurocrine Clinical Site | Recruiting | Watertown | Massachusetts | 02472 | United States |
| Neurocrine Clinical Site | Recruiting | Marlton | New Jersey | 08053 | United States |
| Neurocrine Clinical Site | Recruiting | Staten Island | New York | 10314 | United States |
| Neurocrine Clinical Site | Recruiting | The Bronx | New York | 10461 | United States |
| Neurocrine Clinical Site | Recruiting | Austin | Texas | 78754 | United States |
| Neurocrine Clinical Site | Recruiting | DeSoto | Texas | 75115 | United States |
| Neurocrine Clinical Site | Recruiting | Houston | Texas | 77043 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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