Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia
The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and 50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects with schizophrenia or schizoaffective disorder.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Open-Label, Dose Titration Study to Evaluate the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder|
- Assessment of Tardive Dyskinesia symptoms [ Time Frame: 19 days ] [ Designated as safety issue: No ]Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale
- Number of Participants with Adverse Events following dosing with NBI-98854 [ Time Frame: 19 days ] [ Designated as safety issue: Yes ]
Outcome assessment includes monitoring of:
- Adverse events
- Clinical laboratory tests
- Vital signs
- Physical examinations
- 12-lead electrocardiogram (ECG)
- Evaluate pharmacokinetics of three doses of NBI-98854 [ Time Frame: 19 days ] [ Designated as safety issue: No ]Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.
|Study Start Date:||January 2011|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Open-label, dose titration of active drug
powder in bottle, prepared doses at 12.5, 25, and 50 mg q.d. administered for up to 12 days consisting of three treatment periods of 4 days each
This is a Phase 2, open-label, dose titration study to assess the efficacy and safety of three once daily (q.d.) doses (12.5, 25, and 50 mg) of NBI-98854 administered once daily for up to 12 days consisting of three treatment periods of 4 days each (Periods 1, 2, and 3). The starting dose will be 12.5 mg q.d. (Period 1), and this dose will be escalated to 25 mg q.d. (Period 2) and then to 50 mg q.d. (Period 3) based upon each subject's ability to tolerate NBI-98854. Progression to the next dose level will be based upon the subject's ability to tolerate the previous dose and the Investigator's review of adverse events and safety data. For subjects who do not tolerate a dose increase, the dose may be decreased to the dose that was previously administered (i.e., 25 mg to 12.5 mg, 50 mg to 25 mg) and continued at that dose for the remainder of the study treatment. Up to 10 medically stable subjects with schizophrenia or schizoaffective disorder who have moderate or severe symptoms of TD will be enrolled as outpatients.