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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524104-30-00 | EU Trial (CTIS) Number |
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The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI-1065890 | Experimental | Participants will receive NBI-1065890. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching NBI-1065890. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-1065890 | Drug | Oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are a Clinical Global Impression - Improvement (CGI-I) Responder 1 at Week 8 | Week 8 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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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 | Bryant | Arkansas | 72022 | United States | |
| Neurocrine Clinical Site |
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| Drug |
Oral administration |
|
| Recruiting |
| Chino |
| California |
| 91710 |
| United States |
| Neurocrine Clinical Site | Recruiting | Fountain Valley | California | 92708 | United States |
| Neurocrine Clinical Site | Recruiting | Huntington Beach | California | 92648 | United States |
| Neurocrine Clinical Site | Recruiting | Long Beach | California | 90807 | United States |
| Neurocrine Clinical Site | Recruiting | Temecula | California | 92591 | United States |
| Neurocrine Clinical Site | Recruiting | Torrance | California | 90501 | United States |
| Neurocrine Clinical Site | Recruiting | Boca Raton | Florida | 33486 | United States |
| Neurocrine Clinical Site | Recruiting | Bonita Springs | Florida | 34134 | United States |
| Neurocrine Clinical Site | Recruiting | Hialeah | Florida | 33012 | United States |
| Neurocrine Clinical Site | Recruiting | Miami | Florida | 33176 | United States |
| Neurocrine Clinical Site | Recruiting | Orange City | Florida | 32763 | United States |
| Neurocrine Clinical Site | Recruiting | Tampa | Florida | 33629 | United States |
| Neurocrine Clinical Site | Recruiting | Marietta | Georgia | 30060 | United States |
| Neurocrine Clinical Site | Recruiting | Lincoln | Nebraska | 68526 | United States |
| Neurocrine Clinical Site | Recruiting | Beachwood | Ohio | 44122 | United States |
| Neurocrine Clinical Site | Recruiting | Fort Worth | Texas | 76104 | United States |
| Neurocrine Clinical Site | Recruiting | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D000071057 | Tardive Dyskinesia |
| ID | Term |
|---|---|
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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