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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01688037
First Posted: September 19, 2012
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurocrine Biosciences
September 11, 2012
September 19, 2012
May 11, 2017
November 8, 2017
November 8, 2017
September 2012
September 2013   (Final data collection date for primary outcome measure)
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).
  • 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
Complete list of historical versions of study NCT01688037 on ClinicalTrials.gov Archive Site
  • 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).
  • 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 ]
    Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.
Not Provided
  • 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)
  • Biomarker analysis [ Time Frame: Baseline; Weeks 2, 6, 12, and 16 ]
    Collection of plasma samples for biomarker analysis using a metabolomics approach
 
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
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
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

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
  • placebo

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tardive Dyskinesia
  • Drug: NBI-98854
    25 mg capsule
  • Drug: NBI-98854
    50 mg capsule
  • Drug: Placebo
  • 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.
    Intervention: Drug: NBI-98854
  • 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.
    Interventions:
    • Drug: NBI-98854
    • Drug: NBI-98854
  • Placebo Comparator: Placebo
    Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
October 2013
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening.
  • Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.
  • Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
  • Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
  • Female subjects must not be pregnant.
  • Be in good general health and expected to complete the clinical study as designed.
  • Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
  • Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.
  • Have a negative alcohol breath test at screening and study start.

Exclusion Criteria:

  • Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
  • Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary).
  • Have a known history of neuroleptic malignant syndrome.
  • Have a significant risk of suicidal or violent behavior.
  • Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine.
  • Receiving medication for the treatment of tardive dyskinesia.
  • Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
  • Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
  • Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
  • Have had previous exposure with NBI-98854.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01688037
NBI-98854-1201
No
Not Provided
Not Provided
Neurocrine Biosciences
Neurocrine Biosciences
Not Provided
Study Director: Chris O'Brien, MD Neurocrine Biosciences
Neurocrine Biosciences
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP