Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia (Kinect 4)

November 29, 2018 updated by: Neurocrine Biosciences

A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

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

    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • San Juan, Puerto Rico
    • California
      • Anaheim, California, United States
      • Glendale, California, United States
      • Irvine, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Oakland, California, United States
      • San Bernardino, California, United States
      • San Diego, California, United States
      • Torrance, California, United States
    • Delaware
      • Hockessin, Delaware, United States
    • Florida
      • Bradenton, Florida, United States
      • Hialeah, Florida, United States
      • Kissimmee, Florida, United States
      • Miami, Florida, United States
      • North Miami, Florida, United States
      • Orlando, Florida, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Natick, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New York
      • Buffalo, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • High Point, North Carolina, United States
    • Ohio
      • Dayton, 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
    • Texas
      • DeSoto, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Irving, Texas, United States
    • Virginia
      • Petersburg, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • 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 general good health.
  8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  9. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, 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, 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 prior to screening (some exceptions allowed).
  7. Have received an investigational drug within 30 days before 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. 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Group 1
Fixed dose of NBI-98854 administered once daily for 48 weeks
Experimental: Dose Group 2
Fixed dose of NBI-98854 administered once daily up to 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Monitored for Long-Term Safety of Valbenazine
Time Frame: 52 weeks
Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters
Time Frame: Baseline and Week 48
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site 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 48
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters
Time Frame: Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the 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, Change from Baseline at Week 8, and Change from Baseline at Week 52
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters
Time Frame: Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS 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, Change from Baseline at Week 8, and Change from Baseline at Week 52
Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48
Time Frame: Week 48
Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Week 48

Collaborators and Investigators

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

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.

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

March 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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