NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
|ClinicalTrials.gov Identifier: NCT01688037|
Recruitment Status : Completed
First Posted : September 19, 2012
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tardive Dyskinesia||Drug: NBI-98854 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
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.
- Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6 [ Time Frame: Baseline and Week 6 ]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. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI-98854 50+100 mg group and placebo group analyzed using the ANCOVA model (LOCF, ITT analysis set).
- Clinical Global Impression - Global Improvement of TD (CGI-TD) [ Time Frame: Week 6 ]Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse). The ANOVA analysis of CGI-TD was conducted for the pooled NBI-98854 50+100 mg group and placebo group.
- Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2 [ Time Frame: Week 2 ]Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688037
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|Study Director:||Chris O'Brien, MD||Neurocrine Biosciences|