Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

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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

, , 

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

, , 


Verification Date

November 2018