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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants Monitored for Long-term Safety of Valbenazine
Secondary Outcome
Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
Condition
Tardive Dyskinesia
Intervention
Valbenazine
Study Arms / Comparison Groups
Valbenazine
Description: Fixed dose of valbenazine administered once daily for up to 72 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
161
Start Date
June 13, 2016
Completion Date
June 30, 2017
Primary Completion Date
June 30, 2017
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.
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02736955
Organization ID
NBI-98854-1506
Responsible Party
Sponsor
Study Sponsor
Neurocrine Biosciences
Study Sponsor
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Verification Date
November 2018