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Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736955
Recruitment Status : Completed
First Posted : April 13, 2016
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tardive Dyskinesia
Intervention Drug: Valbenazine
Enrollment 161
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Hide Arm/Group Description Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks 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 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
Period Title: Overall Study
Started 36 117 8
Completed 29 103 6
Not Completed 7 14 2
Arm/Group Title Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg Total
Hide Arm/Group Description Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks. 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 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 Total of all reporting groups
Overall Number of Baseline Participants 35 117 8 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 117 participants 8 participants 160 participants
57.3  (8.9) 57.9  (8.8) 59.3  (9.0) 57.9  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 117 participants 8 participants 160 participants
Female
22
  62.9%
54
  46.2%
3
  37.5%
79
  49.4%
Male
13
  37.1%
63
  53.8%
5
  62.5%
81
  50.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 117 participants 8 participants 160 participants
Hispanic or Latino
4
  11.4%
52
  44.4%
1
  12.5%
57
  35.6%
Not Hispanic or Latino
31
  88.6%
65
  55.6%
7
  87.5%
103
  64.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 117 participants 8 participants 160 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
  12.5%
1
   0.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.6%
Black or African American
14
  40.0%
30
  25.6%
3
  37.5%
47
  29.4%
White
21
  60.0%
86
  73.5%
4
  50.0%
111
  69.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index (BMI) at Baseline  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 35 participants 117 participants 8 participants 160 participants
29.15  (5.52) 28.54  (5.48) 30.55  (5.29) 28.77  (5.46)
Primary Psychiatric Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 117 participants 8 participants 160 participants
Schizophrenia/schizoaffective disorder
23
  65.7%
75
  64.1%
6
  75.0%
104
  65.0%
Mood disorder
12
  34.3%
42
  35.9%
2
  25.0%
56
  35.0%
Age at Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Schizophrenia/Schizoaffective Disorder Number Analyzed 18 participants 72 participants 6 participants 96 participants
27.1  (8.3) 28.7  (11.4) 25.3  (6.2) 28.2  (10.6)
Mood Disorder Number Analyzed 11 participants 42 participants 2 participants 55 participants
36.0  (3.6) 33.9  (2.1) 46.0  (14.0) 34.7  (1.8)
Tardive Dyskinesia Number Analyzed 25 participants 91 participants 8 participants 124 participants
48.3  (11.2) 48.4  (9.5) 43.8  (13.7) 48.0  (10.1)
[1]
Measure Analysis Population Description: Age at diagnosis was not available for some participants.
Scales   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
BPRS Score Number Analyzed 35 participants 117 participants 8 participants 160 participants
27.3  (6.3) 26.1  (5.6) 30.5  (9.2) 26.6  (6.0)
CGI-TD-Severity Score Number Analyzed 35 participants 116 participants 8 participants 159 participants
3.9  (1.1) 3.9  (1.3) 4.3  (0.7) 3.9  (1.2)
[1]
Measure Description:

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.

[2]
Measure Analysis Population Description: Baseline CGI-TD-Severity Score is not available for one participant in the 80 mg valbenazine oral capsule treatment arm.
1.Primary Outcome
Title Number of Participants Monitored for Long-term Safety of Valbenazine
Hide Description 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.
Time Frame 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Hide Arm/Group Description:
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks.
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
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
Overall Number of Participants Analyzed 35 117 8
Measure Type: Count of Participants
Unit of Measure: Participants
35
 100.0%
117
 100.0%
8
 100.0%
2.Secondary Outcome
Title Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Hide Description 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."
Time Frame Baseline and Weeks 12, 24, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Hide Arm/Group Description:
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks
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
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
Overall Number of Participants Analyzed 35 117 8
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 35 participants 116 participants 8 participants
2
   5.7%
21
  18.1%
0
   0.0%
Week 12 Number Analyzed 31 participants 115 participants 8 participants
15
  48.4%
56
  48.7%
3
  37.5%
Week 24 Number Analyzed 23 participants 96 participants 6 participants
11
  47.8%
56
  58.3%
4
  66.7%
Week 36 Number Analyzed 18 participants 68 participants 5 participants
7
  38.9%
44
  64.7%
2
  40.0%
Week 48 Number Analyzed 12 participants 39 participants 5 participants
5
  41.7%
29
  74.4%
2
  40.0%
Week 60 Number Analyzed 2 participants 2 participants 0 participants
2
 100.0%
2
 100.0%
3.Secondary Outcome
Title Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Hide Description 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."
Time Frame Baseline and Weeks 12, 24, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Hide Arm/Group Description:
Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks
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
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
Overall Number of Participants Analyzed 35 117 8
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 35 participants 117 participants 8 participants
35
 100.0%
116
  99.1%
7
  87.5%
Week 12 Number Analyzed 31 participants 115 participants 7 participants
30
  96.8%
112
  97.4%
6
  85.7%
Week 24 Number Analyzed 23 participants 96 participants 6 participants
23
 100.0%
92
  95.8%
6
 100.0%
Week 36 Number Analyzed 18 participants 68 participants 5 participants
17
  94.4%
66
  97.1%
5
 100.0%
Week 48 Number Analyzed 12 participants 39 participants 5 participants
12
 100.0%
38
  97.4%
5
 100.0%
Week 60 Number Analyzed 2 participants 2 participants 0 participants
2
 100.0%
2
 100.0%
Time Frame Up to 60 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Hide Arm/Group Description Participants received 40 mg valbenazine oral capsule once daily for up to 60 weeks. 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 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
All-Cause Mortality
Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   3/117 (2.56%)   1/8 (12.50%) 
Hide Serious Adverse Events
Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/35 (8.57%)   11/117 (9.40%)   2/8 (25.00%) 
Cardiac disorders       
Atrial fibrillation † 1  1/35 (2.86%)  0/117 (0.00%)  0/8 (0.00%) 
Hypertensive heart disease † 1  0/35 (0.00%)  0/117 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders       
Diarrhoea † 1  1/35 (2.86%)  0/117 (0.00%)  0/8 (0.00%) 
General disorders       
Non-cardiac chest pain † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Infections and infestations       
Gangrene † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Sepsis syndrome † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Pneumonia † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Injury, poisoning and procedural complications       
Hip fracture † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Metabolism and nutrition disorders       
Gout † 1  0/35 (0.00%)  0/117 (0.00%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders       
Rhabdomyolysis † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Back pain † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Nervous system disorders       
Coma † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Haemorrhagic stroke † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Psychiatric disorders       
Aggression † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Psychotic disorder † 1  1/35 (2.86%)  0/117 (0.00%)  0/8 (0.00%) 
Depression † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Paranoia † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Mental status changes † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Renal and urinary disorders       
Renal failure † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease † 1  0/35 (0.00%)  1/117 (0.85%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (12.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Valbenazine 40 mg Valbenazine 80 mg Valbenazine 40/80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/35 (17.14%)   23/117 (19.66%)   6/8 (75.00%) 
Infections and infestations       
Urinary tract infection † 1  1/35 (2.86%)  6/117 (5.13%)  0/8 (0.00%) 
Upper respiratory tract infection † 1  1/35 (2.86%)  5/117 (4.27%)  0/8 (0.00%) 
Injury, poisoning and procedural complications       
Fall † 1  1/35 (2.86%)  4/117 (3.42%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain † 1  2/35 (5.71%)  4/117 (3.42%)  0/8 (0.00%) 
Nervous system disorders       
Somnolence † 1  1/35 (2.86%)  0/117 (0.00%)  5/8 (62.50%) 
Headache † 1  1/35 (2.86%)  4/117 (3.42%)  0/8 (0.00%) 
Tremor † 1  0/35 (0.00%)  3/117 (2.56%)  2/8 (25.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  2/35 (5.71%)  3/117 (2.56%)  1/8 (12.50%) 
1
Term from vocabulary, MedDRA (12.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Neurocrine Medical Information
Organization: Neurocrine Biosciences, Inc.
Phone: 877-641-3461
EMail: medinfo@neurocrine.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02736955    
Other Study ID Numbers: NBI-98854-1506
First Submitted: April 8, 2016
First Posted: April 13, 2016
Results First Submitted: October 10, 2018
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018