Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia

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Brief Title

Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia

Official Title

A Phase 2, Open-Label, Dose Titration Study to Evaluate the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

Brief Summary

      The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and
      50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects
      with schizophrenia or schizoaffective disorder.
    

Detailed Description

      This is a Phase 2, open-label, dose titration study to assess the efficacy and safety of
      three once daily (q.d.) doses (12.5, 25, and 50 mg) of NBI-98854 administered once daily for
      up to 12 days consisting of three treatment periods of 4 days each (Periods 1, 2, and 3). The
      starting dose will be 12.5 mg q.d. (Period 1), and this dose will be escalated to 25 mg q.d.
      (Period 2) and then to 50 mg q.d. (Period 3) based upon each subject's ability to tolerate
      NBI-98854. Progression to the next dose level will be based upon the subject's ability to
      tolerate the previous dose and the Investigator's review of adverse events and safety data.
      For subjects who do not tolerate a dose increase, the dose may be decreased to the dose that
      was previously administered (i.e., 25 mg to 12.5 mg, 50 mg to 25 mg) and continued at that
      dose for the remainder of the study treatment. Up to 10 medically stable subjects with
      schizophrenia or schizoaffective disorder who have moderate or severe symptoms of TD will be
      enrolled as outpatients.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Assessment of Tardive Dyskinesia symptoms

Secondary Outcome

 Number of Participants with Adverse Events following dosing with NBI-98854

Condition

Tardive Dyskinesia

Intervention

NBI-98854

Study Arms / Comparison Groups

 NBI-98854
Description:  Open-label, dose titration of active drug

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

10

Start Date

January 2011

Completion Date

March 2011

Primary Completion Date

March 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Males or females (non-childbearing potential) aged 18 to 65 years (both inclusive).

          -  Have moderate or severe Tardive Dyskinesia symptoms (Total AIMS score of at least 9)

          -  Have a clinical diagnosis of schizophrenia or schizoaffective disorder.

          -  Receiving a stable dose of antipsychotic medication for a minimum of 30 days or have
             stable psychiatric status.

          -  Doses of concurrent medications and the conditions being treated have been stable for
             a minimum of 30 days and expected to remain stable during the study.

          -  Are in good general health and expected to complete the clinical study as designed.

          -  Have a body mass index (BMI) of 18 to 38 kg/m^2.

          -  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 (30
             days) prior to screening.

          -  Have a history of substance dependence or substance (drug) or alcohol abuse within the
             3 months before study start.

          -  Have a known history of neuroleptic malignant syndrome.

          -  Have a significant risk of suicidal or violent behavior.

          -  Receiving medication for the treatment of Tardive Dyskinesia

          -  Receiving any excluded concomitant medication as specified in the protocol.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01267188

Organization ID

NBI-98854-1001



Study Sponsor

Neurocrine Biosciences


Study Sponsor

, , 


Verification Date

April 2011