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Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

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.
 
ClinicalTrials.gov Identifier: NCT02736955
Recruitment Status : Completed
First Posted : April 13, 2016
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief Summary:
This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: Valbenazine Phase 3

Detailed Description:
This study was terminated after 60 weeks due to the commercial availability of valbenazine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Actual Study Start Date : June 13, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arm Intervention/treatment
Experimental: Valbenazine
Fixed dose of valbenazine administered once daily for up to 72 weeks
Drug: Valbenazine
Other Name: NBI-98854




Primary Outcome Measures :
  1. Number of Participants Monitored for Long-term Safety of Valbenazine [ Time Frame: 60 weeks ]
    Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.


Secondary Outcome Measures :
  1. Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale [ Time Frame: Baseline and Weeks 12, 24, 36, 48, and 60 ]
    Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= "Normal, not at all ill" to 7= "Among the most extremely ill patient"). A clinical response was defined as a CGI-TD-S score equal to "1" or "2."

  2. Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Baseline and Weeks 12, 24, 36, 48, and 60 ]
    Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to "1" or "2."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
  • Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.
  • If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.
  • Be in general good health.
  • Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

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 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 valbenazine) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736955


  Hide Study Locations
Locations
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United States, California
Anaheim, California, United States
National City, California, United States
Norwalk, California, United States
Oakland, California, United States
San Bernardino, California, United States
San Diego, California, United States
Torrance, California, United States
United States, Florida
Hialeah, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, New York
Cedarhurst, New York, United States
United States, Ohio
Dayton, Ohio, United States
Shaker Heights, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Franklin, Tennessee, United States
Memphis, Tennessee, United States
United States, Texas
DeSoto, Texas, United States
Fort Worth, Texas, United States
Irving, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Petersburg, Virginia, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Neurocrine Biosciences
  Study Documents (Full-Text)

Documents provided by Neurocrine Biosciences:
Study Protocol  [PDF] April 19, 2017
Statistical Analysis Plan  [PDF] October 16, 2017


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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02736955     History of Changes
Other Study ID Numbers: NBI-98854-1506
First Posted: April 13, 2016    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs