- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405091
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
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
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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San Juan, Puerto Rico
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California
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Anaheim, California, United States
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Glendale, California, United States
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Irvine, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Oakland, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Delaware
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Hockessin, Delaware, United States
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Florida
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Bradenton, Florida, United States
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Hialeah, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Hawaii
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Honolulu, Hawaii, United States
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Illinois
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Chicago, Illinois, United States
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Louisiana
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Shreveport, Louisiana, United States
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Massachusetts
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Natick, Massachusetts, United States
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Worcester, Massachusetts, United States
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Michigan
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Ann Arbor, Michigan, United States
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Missouri
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Saint Louis, Missouri, United States
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Nebraska
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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New Hampshire
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Nashua, New Hampshire, United States
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New York
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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North Carolina
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High Point, North Carolina, United States
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Ohio
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Dayton, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Pennsylvania
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Conshohocken, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Texas
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DeSoto, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Virginia
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Petersburg, Virginia, United States
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Washington
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Seattle, Washington, United States
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Spokane, Washington, United States
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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:
- 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.
- Female subjects must not be pregnant.
- Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
- Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
- Have moderate or severe TD
- If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
- Be in general good health.
- Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
- Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.
Exclusion Criteria
- Have an active, clinically significant unstable medical condition within 1 month prior to screening.
- Have a known history of substance dependence, substance (drug) or alcohol abuse.
- Have a significant risk of suicidal or violent behavior.
- Have a known history of neuroleptic malignant syndrome.
- Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
- Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
- 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 a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
- Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- 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 |
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Experimental: Dose Group 1
Fixed dose of NBI-98854 administered once daily for 48 weeks
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Experimental: Dose Group 2
Fixed dose of NBI-98854 administered once daily up to 48 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Monitored for Long-Term Safety of Valbenazine
Time Frame: 52 weeks
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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.
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52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Baseline and Week 48
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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
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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.
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Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
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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
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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.
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Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
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Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48
Time Frame: Week 48
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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).
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Week 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31.
- Josiassen RC, Kane JM, Liang GS, Burke J, O'Brien CF. Long-Term Safety and Tolerability of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and a Diagnosis of Schizophrenia or Mood Disorder. Psychopharmacol Bull. 2017 Aug 1;47(3):61-68.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBI-98854-1402
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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