NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder|
- Severity of tardive dyskinesia (TD) symptoms assessed by Abnormal Involuntary Movements Scale (AIMS) [ Time Frame: Baseline ]
- Severity of TD symptoms assessed by AIMS [ Time Frame: Week 2 ]Change from Baseline, Proportion of responders based on reduction from baseline
- Severity of TD symptoms assessed by AIMS [ Time Frame: Week 6 ]Change from Baseline, Proportion of responders based on reduction from baseline
- Clinical global impression - global improvement of TD (CGI-TD) [ Time Frame: Weeks 2 and 6 ]Clinician's perspective of the participant's overall improvement of TD symptoms over time
- Number of Participants with Adverse Events following dosing with NBI-98854 [ Time Frame: Up to 22 weeks ]Proportion of subjects reporting adverse events
- Evaluation of plasma concentrations of NBI-98854 and metabolites following repeated daily doses (50 mg and 100 mg) of NBI-98854 [ Time Frame: Weeks 2, 6, 8, 12, 14, and 16 ]Plasma samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.
- Exploratory efficacy assessment of 50 mg or 100 mg doses of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms [ Time Frame: Weeks 2, 6, 8, 12, and 16 ]Patient Global Impression of Change (PGIC) questionnaire.
- Exploratory efficacy assessment of 50 mg or 100 mg doses of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms [ Time Frame: Baseline; Weeks 2, 6, 12, and 16 ]Tardive Dyskinesia Ratings Scale (TDRS)
|Study Start Date:||September 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: NBI-98854 50 mg
NBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.
25 mg capsule
Experimental: NBI-98854 100 mg and 50 mg
NBI-98854 100 mg administered as two (2) 50 mg capsules taken every morning between 7:00am - 10:00am for 2 weeks. After 2 weeks, NBI-98854 50 mg administered by two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for remaining 4 weeks.
25 mg capsuleDrug: NBI-98854
50 mg capsule
Placebo Comparator: Placebo
Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for up to 2 weeks. The study will also allow for an evaluation of the efficacy of NBI-98854 50 mg once daily for up to 6 weeks and the safety and tolerability of NBI 98854 50 mg once daily for up to 12 weeks.
The double-blind placebo-controlled treatment period the study has three arms:
- NBI-98854 50 mg once daily for 6 weeks
- NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4 weeks
At the end of the 6-week placebo-controlled double-blind treatment period, subjects will continue in the study for an additional 6-week open-label period where all subjects who have completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and four weeks after the last dose of study drug, follow-up assessments will be performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688037
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|Study Director:||Chris O'Brien, MD||Neurocrine Biosciences|