Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI-1117568 | Experimental | All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period. |
|
| Placebo | Placebo Comparator | All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-1117568 | Drug | Oral capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to Relapse | Up to approximately 30 weeks |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
| 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 | Garden Grove | California | 92845 | United States | |
Not provided
Not provided
Not provided
Not provided
The initial Open-label Stabilization Period is open-label and non-randomized.
| Placebo |
| Drug |
Oral capsules |
|
| Neurocrine Clinical Site |
| Recruiting |
| La Habra |
| California |
| 90631 |
| United States |
| Neurocrine Clinical Site | Recruiting | Lemon Grove | California | 91945 | United States |
| Neurocrine Clinical Site | Recruiting | Oceanside | California | 92056 | United States |
| Neurocrine Clinical Site | Recruiting | Torrance | California | 90504 | United States |
| Neurocrine Clinical Site | Recruiting | West Hills | California | 91307 | United States |
| Neurocrine Clinical Site | Recruiting | Hollywood | Florida | 33024 | United States |
| Neurocrine Clinical Site | Recruiting | Maitland | Florida | 32751 | United States |
| Neurocrine Clinical Site | Recruiting | Miami | Florida | 33122 | United States |
| Neurocrine Clinical Site | Recruiting | Miami | Florida | 33155 | United States |
| Neurocrine Clinical Site | Recruiting | Tampa | Florida | 33629 | United States |
| Neurocrine Clinical Site | Recruiting | West Palm Beach | Florida | 33024 | United States |
| Neurocrine Clinical Site | Recruiting | Atlanta | Georgia | 30318 | United States |
| Neurocrine Clinical Site | Recruiting | Boston | Massachusetts | 02116 | United States |
| Neurocrine Clinical Site | Recruiting | Flowood | Mississippi | 39232 | United States |
| Neurocrine Clinical Site | Recruiting | Cedarhurst | New York | 11516 | United States |
| Neurocrine Clinical Site | Recruiting | New York | New York | 10029 | United States |
| Neurocrine Clinical Site | Recruiting | New York | New York | 10036 | United States |
| Neurocrine Clinical Site | Recruiting | The Bronx | New York | 10461 | United States |
| Neurocrine Clinical Site | Recruiting | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided