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This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valbenazine | Experimental | Valbenazine administered once daily for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valbenazine | Drug | Valbenazine capsules for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24 | The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact. | Baseline, Week 24 |
| Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24 | The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item. | Baseline, Week 24 |
| Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24 | Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGI-C) Score at Week 24 | Participants rated the change in their TD symptoms from the initiation of study treatment dosing by choosing one of 7 responses (1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, and 7=very much worse). Number of participants with PGI-C score responses are reported. | Week 24 |
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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 | Bryant | Arkansas | 72022 | United States | ||
| Neurocrine Clinical Site |
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Results are reported for the overall population as a single arm irrespective of dose, as pre-specified in the protocol. Individual participants could receive different dose levels over the duration of the treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Valbenazine | Participants received valbenazine oral capsules once a day (qd) at a dose of either 40 milligrams (mg), 60 mg or 80 mg for up to 24 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 | Jan 29, 2024 | Dec 17, 2025 |
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| Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24 | The CGI-TD-S is based on a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patients), was used to rate the overall global severity of TD. | Baseline, Week 24 |
| Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24 | The AIMS dyskinesia total score was defined as the sum of the scores of AIMS items 1 through 7. The scores for each item ranged from 0 (no dyskinesia) to 4 (severe dyskinesia). If any of the seven items had a missing value, the total score for that participant/visit was set equal to missing. The AIMS dyskinesia total score can therefore range from 0 to 28, with higher scores indicating greater severity. | Baseline, Week 24 |
| Anaheim |
| California |
| 92805 |
| United States |
| Neurocrine Clinical Site | Orange | California | 92868 | United States |
| Neurocrine Clinical Site | Torrance | California | 90504 | United States |
| Neurocrine Clinical Site | Bonita Springs | Florida | 34134 | United States |
| Neurocrine Clinical Site | Miami | Florida | 33176 | United States |
| Neurocrine Clinical Site | Miami Lakes | Florida | 33016 | United States |
| Neurocrine Clinical Site | Okeechobee | Florida | 34972 | United States |
| Neurocrine Clinical Site | Tampa | Florida | 33629 | United States |
| Neurocrine Clinical Site | Atlanta | Georgia | 30328 | United States |
| Neurocrine Clinical Site | Augusta | Georgia | 30912 | United States |
| Neurocrine Clinical Site | Marietta | Georgia | 30060 | United States |
| Neurocrine Clinical Site | Lincoln | Nebraska | 68526 | United States |
| Neurocrine Clinical Site | Beechwood | Ohio | 44122 | United States |
| Neurocrine Clinical Site | Oklahoma City | Oklahoma | 73112 | United States |
| Neurocrine Clinical Site | DeSoto | Texas | 75115 | United States |
| Neurocrine Clinical Site | El Paso | Texas | 79902 | United States |
| Neurocrine Clinical Site | Houston | Texas | 77030 | United States |
| Received at Least 1 Dose of Valbenazine |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Valbenazine | Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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 | Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24 | The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact. | The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 24 |
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| Primary | Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24 | The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item. | The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed. "Number Analyzed" = participants evaluable for specified SDS item. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 24 |
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| Primary | Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24 | Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health. | The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 24 |
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| Secondary | Patient Global Impression of Change (PGI-C) Score at Week 24 | Participants rated the change in their TD symptoms from the initiation of study treatment dosing by choosing one of 7 responses (1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, and 7=very much worse). Number of participants with PGI-C score responses are reported. | The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24 | The CGI-TD-S is based on a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patients), was used to rate the overall global severity of TD. | The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 24 |
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| Secondary | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24 | The AIMS dyskinesia total score was defined as the sum of the scores of AIMS items 1 through 7. The scores for each item ranged from 0 (no dyskinesia) to 4 (severe dyskinesia). If any of the seven items had a missing value, the total score for that participant/visit was set equal to missing. The AIMS dyskinesia total score can therefore range from 0 to 28, with higher scores indicating greater severity. | The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 24 |
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Up to 26 weeks
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
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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 | Participants received valbenazine oral capsules qd at a dose of either 40 mg, 60 mg or 80 mg for up to 24 weeks. | 1 | 59 | 6 | 59 | 6 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peptic ulcer | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (26.0) | Systematic Assessment |
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| Medication error | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information | Neurocrine Biosciences | +1 877-641-3461 | medinfo@neurocrine.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2025 | Dec 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D000071057 | Tardive Dyskinesia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |
| 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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| Unknown or Not Reported |
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| Black or African American |
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| White |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Multiple |
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