A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia (KINECT 3)

June 9, 2017 updated by: Neurocrine Biosciences

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel, Fixed-Dose Study to Assess the Efficacy, Safety, and Tolerability of NBI-98854 for the Treatment of Tardive Dyskinesia

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Puerto Rico
      • Caguas, Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Glendale, California, United States
      • Irvine, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • National City, California, United States
      • Norwalk, California, United States
      • Oakland, California, United States
      • Oceanside, California, United States
      • San Bernardino, California, United States
      • San Diego, California, United States
      • Torrance, California, United States
    • Florida
      • Bradenton, Florida, United States
      • Hialeah, Florida, United States
      • Kissimmee, Florida, United States
      • Leesburg, Florida, United States
      • Maitland, Florida, United States
      • Miami, Florida, United States
      • North Miami, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
      • Oak Brook, Illinois, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Glen Burnie, Maryland, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Mississippi
      • Flowood, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New York
      • Amherst, New York, United States
      • Cedarhurst, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Pinehurst, North Carolina, United States
    • Ohio
      • Dayton, Ohio, United States
      • Shaker Heights, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Conshohocken, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Phoenixville, Pennsylvania, United States
      • Scranton, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • DeSoto, Texas, United States
      • Fort Worth, Texas, United States
      • Irving, Texas, United States
    • Virginia
      • Petersburg, Virginia, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study.
  2. Female subjects must not be pregnant.
  3. Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder.
  4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
  5. Have moderate or severe TD.
  6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
  7. Be in good general health.
  8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, phencyclidine, cocaine, opiates, or cannabinoids

Exclusion Criteria:

  1. Have an active, clinically significant unstable medical condition within 1 month prior to screening.
  2. Have a known history of substance dependence, or substance (drug) or alcohol abuse
  3. Have a significant risk of suicidal or violent behavior.
  4. Have a known history of neuroleptic malignant syndrome.
  5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
  6. Have a cancer diagnosis within 3 years of screening (some exceptions allowed)
  7. Have received an investigational drug within 30 days prior to screening or plan to use an investigational drug (other than NBI-98854) during the study.
  8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
  9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
  10. Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
  11. Are currently pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBI-98854 40 mg
NBI-98854 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.
Drug: NBI-98854
NBI-98854 40 mg capsules
Drug: Placebo
NBI-98854 placebo capsules
Experimental: NBI-98854 80 mg
Subjects randomized to the NBI-98854 80 mg dose will receive NBI-98854 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by NBI-98854 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning between 7:00am - 10:00am for 5 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.
Drug: NBI-98854
NBI-98854 40 mg capsules
Drug: Placebo
NBI-98854 placebo capsules
Experimental: Placebo
Placebo administered as two (2) placebo capsules, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and be randomized to either a 40 mg or 80 mg dose. Subjects re-randomized to receive NBI-98854 80 mg will receive 40 mg for the first week.
Drug: NBI-98854
NBI-98854 40 mg capsules
Drug: Placebo
NBI-98854 placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6
Time Frame: Baseline and Week 6
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. 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.
Baseline and Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Change - TD (CGI-TD) at Week 6
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).
Week 6
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6
Time Frame: Week 6
Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Principal Investigator: Chris O'Brien, MD, Neurocrine Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-98854-1304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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