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Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 | Experimental | Fixed dose of NBI-98854 administered once daily for 48 weeks |
|
| Dose Group 2 | Experimental | Fixed dose of NBI-98854 administered once daily up to 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-98854 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Monitored for Long-Term Safety of Valbenazine | Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40265997 | Derived | Sajatovic M, Alexopoulos GS, Jen E, Farahmand K, Zinger C. Improvements Over Time with Valbenazine in Elderly Adults (>/=65 Years) with Tardive Dyskinesia: Post Hoc Analyses of 2 Long-Term Studies. J Clin Psychiatry. 2025 Apr 23;86(2):24m15550. doi: 10.4088/JCP.24m15550. | |
| 31617235 | Derived | Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31. |
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This study enrolled participants with clinical diagnoses of schizophrenia or schizoaffective disorder or mood disorder with neuroleptic-induced tardive dyskinesia (TD) from 45 centers in North America and Puerto Rico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Valbenazine 40mg | Participants received valbenazine 40mg capsule once daily for up to 48 weeks. |
| FG001 | Valbenazine 80mg | Participants received valbenazine 40mg once daily for 4 weeks, then 80mg once daily for up to 44 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2015 | Sep 11, 2018 |
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| Baseline and Week 48 |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the blinded, Central AIMS Video Raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 |
| Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48 | Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse). | Week 48 |
| Glendale |
| California |
| United States |
| Irvine | California | United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Oakland | California | United States |
| San Bernardino | California | United States |
| San Diego | California | United States |
| Torrance | California | United States |
| Hockessin | Delaware | United States |
| Bradenton | Florida | United States |
| Hialeah | Florida | United States |
| Kissimmee | Florida | United States |
| Miami | Florida | United States |
| North Miami | Florida | United States |
| Orlando | Florida | United States |
| Honolulu | Hawaii | United States |
| Chicago | Illinois | United States |
| Shreveport | Louisiana | United States |
| Natick | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| St Louis | Missouri | United States |
| Lincoln | Nebraska | United States |
| Omaha | Nebraska | United States |
| Nashua | New Hampshire | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| High Point | North Carolina | United States |
| Dayton | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Conshohocken | Pennsylvania | United States |
| Norristown | Pennsylvania | United States |
| Phoenixville | Pennsylvania | United States |
| Scranton | Pennsylvania | United States |
| DeSoto | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Irving | Texas | United States |
| Petersburg | Virginia | United States |
| Seattle | Washington | United States |
| Spokane | Washington | United States |
| Vancouver | British Columbia | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| San Juan | Puerto Rico |
| FG002 | Valbenazine 80/40mg | Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set: included all participants who are enrolled into the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected
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| ID | Title | Description |
|---|---|---|
| BG000 | Valbenazine 40mg | Participants received valbenazine 40mg once daily for up to 48 weeks. |
| BG001 | Valbenazine 80mg | Participants received valbenazine 40mg once daily for 4 weeks, then 80mg once daily for up to 44 weeks. |
| BG002 | Valbenazine 80/40mg | Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| BMI at Screening | Mean | Full Range | kg/m^2 |
| ||||||||||
| Primary Psychiatric Diagnosis | Count of Participants | Participants |
| |||||||||||
| Age at Diagnosis | Date of diagnosis was not available for some participants. | Mean | Full Range | years |
| |||||||||
| Age at Tardive Dyskinesia Diagnosis | Date of diagnosis was not available for some participants. | Mean | Full Range | years |
| |||||||||
| Screening BPRS Total Score | The Brief Psychiatric Rating Scale (BPRS) is a clinician-rated tool designed to assess the severity of psychopathology in participants with schizophrenia and other psychotic disorders (Overall and Gorham, 1962, 1988). The severity of each of the 18 items of the BPRS is rated on a scale of 1 (not present) to 7 (extremely severe) (total score range: 18 to 126). Higher scores represent greater symptom severity. | Mean | Full Range | score on a scale |
| |||||||||
| Baseline AIMS Dyskinesia Total Score | The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Monitored for Long-Term Safety of Valbenazine | Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. | Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected | Posted | Count of Participants | Participants | 52 weeks |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. | Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected | Posted | Mean | Standard Error | score on a scale | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the blinded, Central AIMS Video Raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. | Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected | Posted | Mean | Standard Error | score on a scale | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 |
| |||||||||||||||||||||||||||||||||
| Secondary | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. | Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected | Posted | Mean | Standard Error | score on a scale | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 |
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48 | Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse). | Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected | Posted | Mean | Standard Error | score on a scale | Week 48 |
|
Up to 52 weeks
Adverse events were evaluated at regular study visits throughout the study.
Events with an onset date during the first four weeks of the NBI-98854 treatment period will be summarized separately from events that occur after the Week 4 visit, as all subjects receive the same dose of 40 mg during the first 4 weeks of treatment. Events with an onset date during the NBI-98854 treatment period after Week 4 will be summarized by treatment group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valbenazine 40 mg Through Week 4 | Participants received valbenazine 40mg capsule once daily for 4 weeks. | 0 | 163 | 0 | 163 | 0 | 163 |
| EG001 | Valbenazine 40mg Week 4 Through Week 52 | Participants received valbenazine 40mg capsule once daily for up to 44 weeks from Week 4 through Week 48. | 0 | 35 | 3 | 35 | 5 | 35 |
| EG002 | Valbenazine 80mg Week 4 Through Week 52 | Participants received valbenazine 80mg once daily for up to 44 weeks from Week 4 through Week 48. | 1 | 107 | 17 | 107 | 15 | 107 |
| EG003 | Valbenazine 80/40mg Week 4 Through Week 52 | Participants who were unable to tolerate the 80mg dose had a dose decrease to 40mg capsule once daily for up to 44 weeks from Week 4 through Week 48. | 0 | 11 | 1 | 11 | 1 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment | Dose at time of Joint dislocation event for Valbenazine 80/40mg Week 4 Through Week 52 group was 40 mg. |
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| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Hyponatraemic syndrome | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
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| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
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| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment | Dose at time of Urinary tract infection event for Valbenazine 80/40mg Week 4 Through Week 52 group was 40 mg. |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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Generally, the PI has the right to publish results provided such publication does not violate confidentiality or IP provisions within the contract with the Sponsor. Prior to submission for publication or presentation of results, the PI must provide the Sponsor time for review. The Sponsor can request the PI to withhold or remove information from all publications. For a multi-center study, any publication of results by the PI shall not be made before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information | Neurocrine Biosciences, Inc. | 877-641-3461 | medinfo@neurocrine.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 5, 2016 | Sep 11, 2018 | SAP_001.pdf |
| 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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| ID | Term |
|---|---|
| C000603978 | valbenazine |
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| Black or African American |
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| Caucasian |
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| Native Hawaiian or Other Pacific Islander |
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| Other: Latina |
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| Other: Mulatto |
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| Age at Mood Disorder Diagnosis |
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| Valbenazine 80/40mg |
Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks. |
|
|
| OG002 |
| Valbenazine 80/40mg |
Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks. |
|
|
| OG002 |
| Valbenazine 80/40mg |
Participants received valbenazine 40mg once daily for 4 weeks, then 80 mg. Participants who were unable to tolerate the 80 mg dose had a dose decrease to 40 mg capsule once daily for up to 44 weeks. |
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