Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

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Brief Title

Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Official Title

A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Brief Summary

      Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered
      once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately
      150 medically stable male and female subjects with clinical diagnoses of schizophrenia or
      schizoaffective disorder with neuroleptic-induced TD or mood disorder with
      neuroleptic-induced TD.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants Monitored for Long-Term Safety of Valbenazine

Secondary Outcome

 Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters

Condition

Tardive Dyskinesia

Intervention

NBI-98854

Study Arms / Comparison Groups

 Dose Group 1
Description:  Fixed dose of NBI-98854 administered once daily for 48 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

167

Start Date

March 2015

Completion Date

March 2017

Primary Completion Date

March 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently during the screening,
             treatment and follow-up periods of the study.

          2. Female subjects must not be pregnant.

          3. Have one of the following clinical diagnoses for at least 3 months prior to screening:
             Schizophrenia or Schizoaffective Disorder, or Mood Disorder

          4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to
             screening.

          5. Have moderate or severe TD

          6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or
             mood disorder, be on stable doses.

          7. Be in general good health.

          8. Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

          9. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine,
             phencyclidine, cocaine, opiates, or cannabinoids.

        Exclusion Criteria

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening.

          2. Have a known history of substance dependence, substance (drug) or alcohol abuse.

          3. Have a significant risk of suicidal or violent behavior.

          4. Have a known history of neuroleptic malignant syndrome.

          5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.

          6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

          7. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study.

          8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

          9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

         10. Are currently pregnant or breastfeeding.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02405091

Organization ID

NBI-98854-1402


Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences


Study Sponsor

, , 


Verification Date

November 2018