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NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)

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ClinicalTrials.gov Identifier: NCT01688037
Recruitment Status : Completed
First Posted : September 19, 2012
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tardive Dyskinesia
Interventions: Drug: NBI-98854
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled patients with a clinical diagnosis of schizophrenia or schizoaffective disorder with moderate or severe tardive dyskinesia (TD) from 35 centers in the United States and Puerto Rico. The last patient completed in October 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Double-Blind Placebo, Then Open-Label 50mg

Double-Blind Period: Participants first received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.

Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.

Double-Blind 50mg, Then Open-Label 50mg

Double-Blind Period: Participants first received valbenazine 50mg capsule once daily for 6 weeks.

Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.

Double-Blind 100mg/50mg, Then Open-Label 50mg

Double-Blind Period: Participants first received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.

Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.


Participant Flow for 3 periods

Period 1:   Double-Blind Period (Week 0 to 6)
    Double-Blind Placebo, Then Open-Label 50mg   Double-Blind 50mg, Then Open-Label 50mg   Double-Blind 100mg/50mg, Then Open-Label 50mg
STARTED   54   28   27 
COMPLETED   47   25   21 
NOT COMPLETED   7   3   6 
Adverse Event                1                0                1 
Non-compliance                1                2                3 
Withdrawal by Subject                4                0                1 
Lost to Follow-up                1                0                1 
Physician Decision                0                1                0 

Period 2:   Open-Label Period (Week 6 to 12)
    Double-Blind Placebo, Then Open-Label 50mg   Double-Blind 50mg, Then Open-Label 50mg   Double-Blind 100mg/50mg, Then Open-Label 50mg
STARTED   47   25   21 
COMPLETED   42   22   17 
NOT COMPLETED   5   3   4 
Adverse Event                4                1                1 
Non-compliance                0                0                2 
Withdrawal by Subject                1                2                0 
Lost to Follow-up                0                0                1 

Period 3:   Follow-up Period (Week 12 to 16)
    Double-Blind Placebo, Then Open-Label 50mg   Double-Blind 50mg, Then Open-Label 50mg   Double-Blind 100mg/50mg, Then Open-Label 50mg
STARTED   42   22   17 
COMPLETED   42   21   17 
NOT COMPLETED   0   1   0 
Withdrawal by Subject                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set (all randomized subjects who received at least 1 dose of study drug).

Reporting Groups
  Description
Double-Blind Placebo, Then Open-Label 50mg

Double-Blind Period: Participants first received Placebo capsule (matching valbenazine capsule) once daily for 6 weeks.

Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.

Double-Blind 50mg, Then Open-Label 50mg

Double-Blind Period: Participants first received valbenazine 50mg capsule once daily for 6 weeks.

Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.

Double-Blind 100mg/50mg, Then Open-Label 50mg

Double-Blind Period: Participants first received valbenazine 100mg capsule once daily for 2 weeks, then they received valbenazine 50mg capsule once daily for 4 weeks.

Open-Label Period: Participants received valbenazine 50mg capsule once daily for 6 weeks.

Total Total of all reporting groups

Baseline Measures
   Double-Blind Placebo, Then Open-Label 50mg   Double-Blind 50mg, Then Open-Label 50mg   Double-Blind 100mg/50mg, Then Open-Label 50mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 54   28   27   109 
Age 
[Units: Years]
Mean (Full Range)
       
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
   54.5 
 (27 to 76) 
 55.5 
 (42 to 72) 
 55.6 
 (28 to 77) 
 55.0 
 (27 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
Female      20  37.0%      8  28.6%      9  33.3%      37  33.9% 
Male      34  63.0%      20  71.4%      18  66.7%      72  66.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Black or African American         
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
Black or African American   29   12   7   48 
White         
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
White   23   15   19   57 
Native Hawaiian or Other Pacific Islander         
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
Native Hawaiian or Other Pacific Islander   1   0   0   1 
Other         
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
Other   0   1   0   1 
American Indian or Alaska Native, Black         
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
American Indian or Alaska Native, Black   1   0   1   2 
Body Mass Index 
[Units: Kg/m^2]
Mean (Full Range)
       
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
   28.71 
 (19.2 to 44.2) 
 28.85 
 (18.5 to 42.6) 
 26.39 
 (14.1 to 37.8) 
 28.17 
 (14.1 to 44.2) 
Age at Schizophrenia/Schizoaffective Disorder Diagnosis [1] 
[Units: Years]
Mean (Full Range)
       
Participants Analyzed 
[Units: Participants]
 50   27   25   102 
   29.4 
 (10 to 68) 
 29.7 
 (16 to 66) 
 30.4 
 (17 to 66) 
 29.7 
 (10 to 68) 
[1] Date of diagnosis was not available for some subjects.
Age at TD Diagnosis [1] 
[Units: Years]
Mean (Full Range)
       
Participants Analyzed 
[Units: Participants]
 49   26   22   97 
   46.9 
 (16 to 73) 
 48.5 
 (37 to 67) 
 47.5 
 (22 to 73) 
 47.5 
 (16 to 73) 
[1] Date of diagnosis was not available for some subjects.
BPRS Total Score [1] 
[Units: Units on a scale]
Mean (Full Range)
       
Participants Analyzed 
[Units: Participants]
 54   28   27   109 
   33.8 
 (20 to 48) 
 32.6 
 (22 to 49) 
 33.0 
 (21 to 49) 
 33.3 
 (20 to 49) 
[1] The Brief Psychiatric Rating Scale (BPRS) is a clinician-rated tool designed to assess change in the severity of psychopathology in patients 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.
Baseline AIMS Total Dyskinesia Score [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 54   27   26   107 
   15.3  (4.4)   14.6  (5.9)   14.6  (4.7)   15.0  (4.8) 
[1] 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.
[2] Baseline AIMS Total Dyskinesia Score based on the ITT analysis set.


  Outcome Measures

1.  Primary:   Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:   Clinical Global Impression - Global Improvement of TD (CGI-TD)   [ Time Frame: Week 6 ]

3.  Secondary:   Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2   [ Time Frame: Week 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Neurocrine Medical Information
Organization: Neurocrine Biosciences, Inc.
phone: 877-641-3461
e-mail: medinfo@neurocrine.com



Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT01688037     History of Changes
Other Study ID Numbers: NBI-98854-1201
First Submitted: September 11, 2012
First Posted: September 19, 2012
Results First Submitted: May 11, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017