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This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valbenazine | Experimental | Valbenazine or placebo oral capsules administered once daily for 7 weeks. |
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| Placebo | Placebo Comparator | Placebo oral capsules administered once daily for 7 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valbenazine | Drug | vesicular monoamine transporter 2 (VMAT2) inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Participants With Withdrawal-Emergent Adverse Events | A withdrawal-emergent adverse event is an adverse event that begins during the Withdrawal Period. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Experience Worsening of Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20) | The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Worsening of symptoms is defined by 5 new symptoms of moderate or severe degree or a worsening of symptoms by 2 points on the PWC-20 scale during Weeks 5 to 7 compared with Week 4. Note: a 2-point worsening from 0 (none) at Week 4 to 2 (moderate) post-Week 4 is counted as a worsening of symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Anaheim | California | 92804 | United States | ||
| Neurocrine Clinical Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valbenazine/Placebo | Valbenazine administered once daily for 4 weeks, followed by placebo administered once daily for 3 weeks. |
| FG001 | Placebo/Placebo | Placebo administered once daily for 7 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2019 | May 1, 2020 |
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| Placebo oral capsule | Drug | non-active dosage form |
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| 3 weeks |
| Absolute Worst Total Score as Measured by the Physician Withdrawal Checklist-20 (PWC-20) | The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Larger values indicate more severe symptoms. Rickels et al (J Clin Psychopharmacol 2008) cites PWC-20 mean scores associated with withdrawal in the range of 15 to 24. | 3 weeks |
| Severity of Withdrawal Symptoms as Measured by the Change From Withdrawal Baseline (Week 4) to Week 7 in the Modified Cocaine Selective Severity Assessment (mCSSA) | The mCSSA is an 18-item survey based on symptoms commonly associated with early cocaine abstinence, including depression, fatigue, anhedonia, anxiety, irritability, sleep disturbance, and inability to concentrate. Items are rated on scales of 0 to 7 or 0 to 8, with separate scale descriptions for each item. Larger values indicate more severe symptoms. The scale has been modified to be specific to study drug (valbenazine or placebo) instead of cocaine. | 7 weeks |
| Overall Improvement From Baseline of TD Symptoms as Measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) Score | The CGI-TD-I scale is a 7-point scale (range; 1=very much improved to 7=very much worse) used to assess overall improvement in TD symptoms since the initiation of study drug dosing. | Baseline, Week 4, Week 7 |
| Change in Severity of TD Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) Scale | The CGI-TD-S scale is a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patient) used to assess the overall global severity of TD. | Baseline, Week 4, Week 7 |
| Glendale |
| California |
| 91206 |
| United States |
| Neurocrine Clinical Site | Norwalk | California | 90650 | United States |
| Neurocrine Clinical Site | Oceanside | California | 92054 | United States |
| Neurocrine Clinical Site | San Bernardino | California | 92108 | United States |
| Neurocrine Clinical Site | Hialeah | Florida | 33012 | United States |
| Neurocrine Clinical Site | Hialeah | Florida | 33013 | United States |
| Neurocrine Clinical Site | Hialeah | Florida | 33018 | United States |
| Neurocrine Clinical Site | Honolulu | Hawaii | 96817 | United States |
| Neurocrine Clinical Site | Fort Wayne | Indiana | 46804 | United States |
| Neurocrine Clinical Site | Ann Arbor | Michigan | 48105 | United States |
| Neurocrine Clinical Site | Beechwood | Ohio | 44122 | United States |
| Neurocrine Clinical Site | Oklahoma City | Oklahoma | 73112 | United States |
| Neurocrine Clinical Site | Scranton | Pennsylvania | 18503 | United States |
| Neurocrine Clinical Site | DeSoto | Texas | 75115 | United States |
| Neurocrine Clinical Site | Irving | Texas | 75062 | United States |
| Neurocrine Clinical Site | San Juan | 00926 | Puerto Rico |
| Entered Withdrawal Period |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valbenazine/Placebo | Valbenazine administered once daily for 4 weeks, followed by placebo administered once daily for 3 weeks. |
| BG001 | Placebo/Placebo | Placebo administered once daily for 7 weeks. |
| BG002 | 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 |
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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 (NIH/OMB) | 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 | Participants With Withdrawal-Emergent Adverse Events | A withdrawal-emergent adverse event is an adverse event that begins during the Withdrawal Period. | Dependence and Withdrawal Analysis Set, which includes all participants who were randomized, took at least one dose of study drug, and entered the Withdrawal Period. | Posted | Count of Participants | Participants | 3 weeks |
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| Secondary | Participants Who Experience Worsening of Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20) | The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Worsening of symptoms is defined by 5 new symptoms of moderate or severe degree or a worsening of symptoms by 2 points on the PWC-20 scale during Weeks 5 to 7 compared with Week 4. Note: a 2-point worsening from 0 (none) at Week 4 to 2 (moderate) post-Week 4 is counted as a worsening of symptoms. | Dependence and Withdrawal Analysis Set, which includes all participants who were randomized, took at least one dose of study drug, and entered the Withdrawal Period. | Posted | Count of Participants | Participants | 3 weeks |
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| Secondary | Absolute Worst Total Score as Measured by the Physician Withdrawal Checklist-20 (PWC-20) | The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Larger values indicate more severe symptoms. Rickels et al (J Clin Psychopharmacol 2008) cites PWC-20 mean scores associated with withdrawal in the range of 15 to 24. | Dependence and Withdrawal Analysis Set, which includes all participants who were randomized, took at least one dose of study drug, and entered the Withdrawal Period. | Posted | Mean | Standard Deviation | score on a scale | 3 weeks |
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| Secondary | Severity of Withdrawal Symptoms as Measured by the Change From Withdrawal Baseline (Week 4) to Week 7 in the Modified Cocaine Selective Severity Assessment (mCSSA) | The mCSSA is an 18-item survey based on symptoms commonly associated with early cocaine abstinence, including depression, fatigue, anhedonia, anxiety, irritability, sleep disturbance, and inability to concentrate. Items are rated on scales of 0 to 7 or 0 to 8, with separate scale descriptions for each item. Larger values indicate more severe symptoms. The scale has been modified to be specific to study drug (valbenazine or placebo) instead of cocaine. | Dependence and Withdrawal Analysis Set, which includes all participants who were randomized, took at least one dose of study drug, and entered the Withdrawal Period. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
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| Secondary | Overall Improvement From Baseline of TD Symptoms as Measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) Score | The CGI-TD-I scale is a 7-point scale (range; 1=very much improved to 7=very much worse) used to assess overall improvement in TD symptoms since the initiation of study drug dosing. | Efficacy analysis set was defined as all participants who were randomized to a treatment group, took at least one dose of study drug, and had a CGI-TD-I assessment at Week 4. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 7 |
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| Secondary | Change in Severity of TD Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) Scale | The CGI-TD-S scale is a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patient) used to assess the overall global severity of TD. | Efficacy analysis set was defined as all participants who were randomized to a treatment group, took at least one dose of study drug, and had a CGI-TD-S assessment at Week 4. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 7 |
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Up to 7 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/Placebo | Valbenazine administered once daily for 4 weeks, followed by placebo administered once daily for 3 weeks. | 0 | 44 | 1 | 44 | 12 | 44 |
| EG001 | Placebo/Placebo | Placebo administered once daily for 7 weeks. | 0 | 45 | 1 | 45 | 19 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizoaffective disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (21.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information | Neurocrine Biosciences, Inc. | 877-641-3461 | medinfo@neurocrine.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 16, 2019 | May 1, 2020 | Prot_001.pdf |
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| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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