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Study ATS3020 was closed due to business reasons. Neurocrine Biosciences will continue to conduct study ATS3019 (NCT05110157). There were no unexpected safety findings for this compound that motivated the decision.
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This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valbenazine | Experimental | Valbenazine once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valbenazine | Drug | Oral treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 | Baseline, Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10 | Baseline, Week 10 | |
| Change in Personal and Social Performance (PSP) Score from Baseline to Week 10 | Baseline, Week 10 |
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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 | San Jose | California | 95124 | United States | ||
| 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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| ID | Term |
|---|---|
| C000603978 | valbenazine |
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| Placebo | Drug | Placebo matching valbenazine |
|
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Neurocrine Clinical Site | Atlanta | Georgia | 30328 | United States |