A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

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Brief Title

A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel, Fixed-Dose Study to Assess the Efficacy, Safety, and Tolerability of NBI-98854 for the Treatment of Tardive Dyskinesia

Brief Summary

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
    

Detailed Description

      This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study
      to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80
      mg) compared to placebo, administered once daily. The study design includes a double-blind,
      placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period
      for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments
      will be conducted 4 weeks after the last dose of the study drug.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6

Secondary Outcome

 Clinical Global Impression of Change - TD (CGI-TD) at Week 6

Condition

Tardive Dyskinesia

Intervention

NBI-98854

Study Arms / Comparison Groups

 NBI-98854 40 mg
Description:  NBI-98854 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.

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

234

Start Date

October 2014

Completion Date

July 2016

Primary Completion Date

September 2015

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 good general health.

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

          9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines,
             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, or 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 of screening (some exceptions allowed)

          7. Have received an investigational drug within 30 days prior to 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. Have had previous exposure with NBI-98854 or had previously participated in an
             NBI-98854 clinical study.

         11. Are currently pregnant or breastfeeding.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Chris O'Brien, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02274558

Organization ID

NBI-98854-1304


Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences


Study Sponsor

Chris O'Brien, MD, Principal Investigator, Neurocrine Biosciences


Verification Date

June 2017