Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Primary Purpose
Tardive Dyskinesia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Valbenazine
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valbenazine
Arm Description
Fixed dose of valbenazine administered once daily for up to 72 weeks
Outcomes
Primary Outcome Measures
Number of Participants Monitored for Long-term Safety of Valbenazine
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
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
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."
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
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."
Full Information
NCT ID
NCT02736955
First Posted
April 8, 2016
Last Updated
November 28, 2018
Sponsor
Neurocrine Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT02736955
Brief Title
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Official Title
Open-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 13, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences
4. Oversight
5. Study Description
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.
Detailed Description
This study was terminated after 60 weeks due to the commercial availability of valbenazine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valbenazine
Arm Type
Experimental
Arm Description
Fixed dose of valbenazine administered once daily for up to 72 weeks
Intervention Type
Drug
Intervention Name(s)
Valbenazine
Other Intervention Name(s)
NBI-98854
Primary Outcome Measure Information:
Title
Number of Participants Monitored for Long-term Safety of Valbenazine
Description
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.
Time Frame
60 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Description
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."
Time Frame
Baseline and Weeks 12, 24, 36, 48, and 60
Title
Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
Description
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."
Time Frame
Baseline and Weeks 12, 24, 36, 48, and 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Anaheim
State/Province
California
Country
United States
City
National City
State/Province
California
Country
United States
City
Norwalk
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
San Bernardino
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
North Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Cedarhurst
State/Province
New York
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Shaker Heights
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Norristown
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Franklin
State/Province
Tennessee
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
DeSoto
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Irving
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Petersburg
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32419679
Citation
Lindenmayer JP, Verghese C, Marder SR, Burke J, Jimenez R, Siegert S, Liang GS, O'Brien CF. A long-term, open-label study of valbenazine for tardive dyskinesia. CNS Spectr. 2021 Aug;26(4):345-353. doi: 10.1017/S109285292000108X. Epub 2020 May 18.
Results Reference
derived
Learn more about this trial
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
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