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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521868-35-00 | EU Trial (CTIS) Number |
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The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI-1117570: Lower-dose | Experimental | Participants will receive a lower-dose of NBI-1117570. |
|
| NBI-1117570: Higher-dose | Experimental | Participants will receive a higher-dose of NBI-1117570. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to NBI-1117570. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-1117570 | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35 | Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Event (TEAEs) | Day 1 up to Day 49 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information Call Center | Contact | 1-877-641-3461 | medinfo@neurocrine.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Lead | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Recruiting | Kazanlak | 6100 | Bulgaria | ||
| Neurocrine Clinical Site |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Placebo |
| Drug |
Oral administration |
|
| Recruiting |
| Pazardzhik |
| 4400 |
| Bulgaria |
| Neurocrine Clinical Site | Recruiting | Targovishte | 7700 | Bulgaria |
| Neurocrine Clinical Site | Recruiting | London | SE5 8AZ | United Kingdom |
| Neurocrine Clinical Site | Recruiting | Oxford | OX3 7JX | United Kingdom |