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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521215-39-00 | EU Trial (CTIS) Number |
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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 | Culver City | California | 90230 | United States | |
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| Placebo | Drug | Placebo will be administered per schedule specified in the arm description. |
|
| Neurocrine Clinical Site |
| Recruiting |
| Garden Grove |
| California |
| 92845 |
| United States |
| Neurocrine Clinical Site | Recruiting | Riverside | California | 92506 | United States |
| Neurocrine Clinical Site | Recruiting | Atlanta | Georgia | 30328 | United States |
| Neurocrine Clinical Site | Recruiting | North Canton | Ohio | 44720 | United States |
| Neurocrine Clinical Site | Recruiting | Sliven | 8800 | Bulgaria |
| Neurocrine Clinical Site | Withdrawn | Veliko Tarnovo | 5047 | Bulgaria |
| Neurocrine Clinical Site | Recruiting | Vratsa | 3001 | Bulgaria |
| Neurocrine Clinical Site | Recruiting | Győr | 9024 | Hungary |
| Neurocrine Clinical Site | Recruiting | Brasov | 500123 | Romania |
| Neurocrine Clinical Site | Recruiting | Brasov | 507190 | Romania |
| Neurocrine Clinical Site | Recruiting | Bucharest | 41914 | Romania |
| Neurocrine Clinical Site | Recruiting | Belgrade | 11000 | Serbia |
| Neurocrine Clinical Site | Recruiting | Gornja Toponica | 18202 | Serbia |
| Neurocrine Clinical Site | Recruiting | Kragujevac | 34000 | Serbia |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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