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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT01393600
First received: July 11, 2011
Last updated: July 14, 2017
Last verified: July 2017
Results First Received: May 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Tardive Dyskinesia
Interventions: Drug: NBI-98854
Drug: Placebo

  Participant Flow
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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 symptoms of tardive dyskinesia (TD) from 10 centers in the United States. The last patient completed in February 2012.

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
Placebo, Then Valbenazine 12.5 mg Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 12.5 mg solution once daily from Day 15 to 28.
Valbenazine 12.5 mg, Then Placebo Participants first received valbenazine 12.5 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.
Placebo, Then Valbenazine 50 mg Participants first received Placebo (matching valbenazine solution) once daily from Day 1 to 14, then they received valbenazine 50 mg solution once daily from Day 15 to 28.
Valbenazine 50 mg, Then Placebo Participants first received valbenazine 50 mg solution once daily from Day 1 to 14, then they received Placebo (matching valbenazine solution) once daily from Day 15 to 28.

Participant Flow for 3 periods

Period 1:   Treatment Period 1 (Day 1 to 14)
    Placebo, Then Valbenazine 12.5 mg   Valbenazine 12.5 mg, Then Placebo   Placebo, Then Valbenazine 50 mg   Valbenazine 50 mg, Then Placebo
STARTED   9   8   10   10 
COMPLETED   9   7   9   9 
NOT COMPLETED   0   1   1   1 
Protocol Violation                0                1                0                0 
Withdrawal by Subject                0                0                1                0 
Adverse Event                0                0                0                1 

Period 2:   Treatment Period 2 (Day 15 to 28)
    Placebo, Then Valbenazine 12.5 mg   Valbenazine 12.5 mg, Then Placebo   Placebo, Then Valbenazine 50 mg   Valbenazine 50 mg, Then Placebo
STARTED   9   7   9   9 
COMPLETED   9   7   7   8 
NOT COMPLETED   0   0   2   1 
Withdrawal by Subject                0                0                0                1 
Lost to Follow-up                0                0                1                0 
Physician Decision                0                0                1                0 

Period 3:   Follow-up Period (Day 29 to 35)
    Placebo, Then Valbenazine 12.5 mg   Valbenazine 12.5 mg, Then Placebo   Placebo, Then Valbenazine 50 mg   Valbenazine 50 mg, Then Placebo
STARTED   9   7   7   8 
COMPLETED   9   7   6   8 
NOT COMPLETED   0   0   1   0 
Withdrawal by Subject                0                0                1                0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
All Subjects All randomized subjects who received at least one dose of study drug.

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Years]
Mean (Full Range)
 51.1 
 (29 to 65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  40.5% 
Male      22  59.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Black   12 
Caucasian   15 
Hispanic   10 
Body Mass Index 
[Units: Kg/m^2]
Mean (Full Range)
 29.9 
 (18.1 to 42.0) 
Age of Schizophrenia/Schizoaffective Disorder Diagnosis 
[Units: Years]
Mean (Full Range)
 25.8 
 (8 to 54) 
Age at TD Diagnosis 
[Units: Years]
Mean (Full Range)
 41.7 
 (18 to 63) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score   [ Time Frame: Day 15 and 29, averaged ]

2.  Secondary:   Clinical Global Impression - Global Improvement of TD (CGI-TD)   [ Time Frame: Day 15 and 29, averaged ]

3.  Post-Hoc:   Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site)   [ Time Frame: Day 15 and 29, averaged ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: NCT01393600     History of Changes
Other Study ID Numbers: NBI-98854-1101
Study First Received: July 11, 2011
Results First Received: May 11, 2017
Last Updated: July 14, 2017