Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
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|ClinicalTrials.gov Identifier: NCT02736955|
Recruitment Status : Completed
First Posted : April 13, 2016
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Tardive Dyskinesia||Drug: Valbenazine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Fixed dose of valbenazine administered once daily for up to 72 weeks
Other Name: NBI-98854
- 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.
- 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."
- 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."
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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|
- 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.
- 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.
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
|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|
Documents provided by Neurocrine Biosciences:
|Responsible Party:||Neurocrine Biosciences|
|Other Study ID Numbers:||
|First Posted:||April 13, 2016 Key Record Dates|
|Results First Posted:||December 19, 2018|
|Last Update Posted:||December 19, 2018|
|Last Verified:||November 2018|
Central Nervous System Diseases
Nervous System Diseases