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
|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."
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
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