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.
This study was terminated after 60 weeks due to the commercial availability of valbenazine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Unnamed facility
Anaheim, California, United States
Unnamed facility
National City, California, United States
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.
Time frame: 60 weeks
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."
Time frame: Baseline and Weeks 12, 24, 36, 48, and 60
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."
Time frame: Baseline and Weeks 12, 24, 36, 48, and 60
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Unnamed facility
Norwalk, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
San Bernardino, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
North Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
...and 17 more locations