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This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
This study was terminated after 60 weeks due to the commercial availability of valbenazine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valbenazine | Experimental | Fixed dose of valbenazine administered once daily for up to 72 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valbenazine | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Monitored for Long-term Safety of Valbenazine | Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. | 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= "Normal, not at all ill" to 7= "Among the most extremely ill patient"). A clinical response was defined as a CGI-TD-S score equal to "1" or "2." |
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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 |
|---|---|---|---|
| 32419679 | Derived | Lindenmayer JP, Verghese C, Marder SR, Burke J, Jimenez R, Siegert S, Liang GS, O'Brien CF. A long-term, open-label study of valbenazine for tardive dyskinesia. CNS Spectr. 2021 Aug;26(4):345-353. doi: 10.1017/S109285292000108X. Epub 2020 May 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valbenazine 40 mg | Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks |
| FG001 | Valbenazine 80 mg | Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 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 | Apr 19, 2017 | Oct 10, 2018 |
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| Baseline and Weeks 12, 24, 36, 48, and 60 |
| Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ) | Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to "1" or "2." | Baseline and Weeks 12, 24, 36, 48, and 60 |
| National City |
| California |
| United States |
| Norwalk | California | United States |
| Oakland | California | United States |
| San Bernardino | California | United States |
| San Diego | California | United States |
| Torrance | California | United States |
| Hialeah | Florida | United States |
| North Miami | Florida | United States |
| Orlando | Florida | United States |
| Chicago | Illinois | United States |
| Shreveport | Louisiana | United States |
| Worcester | Massachusetts | United States |
| Cedarhurst | New York | United States |
| Dayton | Ohio | United States |
| Shaker Heights | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Norristown | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Franklin | Tennessee | United States |
| Memphis | Tennessee | United States |
| DeSoto | Texas | United States |
| Fort Worth | Texas | United States |
| Irving | Texas | United States |
| Salt Lake City | Utah | United States |
| Petersburg | Virginia | United States |
| Spokane | Washington | United States |
| FG002 | Valbenazine 40/80 mg | Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valbenazine 40 mg | Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks. |
| BG001 | Valbenazine 80 mg | Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks |
| BG002 | Valbenazine 40/80 mg | Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) at Baseline | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| Primary Psychiatric Diagnosis | Count of Participants | Participants |
| |||||||||||
| Age at Diagnosis | Age at diagnosis was not available for some participants. | Mean | Standard Deviation | years |
| |||||||||
| Scales | The Brief Psychiatric Rating Scale (BPRS) assesses the severity of psychopathology in patients with schizophrenia and other psychotic disorders by addressing 18 items. The severity of each item 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. The Clinical Global Impression of Tardive Dyskinesia-Severity (CGI-TD-severity) scale assesses the overall global severity of TD. The scale has 7 points from 1=normal, not at all ill to 7=among the most extremely ill patient. | Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm. | Mean | Standard Deviation | units on a scale |
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| 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 | Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. | Posted | Count of Participants | Participants | 60 weeks |
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| Secondary | Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= "Normal, not at all ill" to 7= "Among the most extremely ill patient"). A clinical response was defined as a CGI-TD-S score equal to "1" or "2." | 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 | Baseline and Weeks 12, 24, 36, 48, and 60 |
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| Secondary | Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ) | Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to "1" or "2." | 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 | Baseline and Weeks 12, 24, 36, 48, and 60 |
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Up to 60 weeks
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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 | Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks. | 0 | 35 | 3 | 35 | 6 | 35 |
| EG001 | Valbenazine 80 mg | Participants received 40 mg valbenazine oral capsule once daily for 4 weeks, followed by 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily for up to 56 weeks | 3 | 117 | 11 | 117 | 23 | 117 |
| EG002 | Valbenazine 40/80 mg | Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks | 1 | 8 | 2 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Paranoia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Sepsis syndrome | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Coma | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Hypertensive heart disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Renal failure | Renal and urinary 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 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Tremor | 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 | Oct 16, 2017 | Oct 10, 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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| Mood Disorder |
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| Tardive Dyskinesia |
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| CGI-TD-Severity Score |
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Participants received 40 mg valbenazine oral capsule once daily for 4 weeks. Participants were then increased to 80 mg (provided as 2 x 40 mg valbenazine oral capsule) once daily, and due to poor tolerance, were subsequently reduced back to one 40 mg valbenazine oral capsule once daily for the remainder of the study, up to 56 weeks
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