Aim to Reduce Movements in Tardive Dyskinesia

Brief Title

Aim to Reduce Movements in Tardive Dyskinesia

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Brief Summary

      The purpose of this study is to determine whether an investigational drug, SD-809
      (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive
      dyskinesia.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis

Secondary Outcome

 Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)

Condition

Tardive Dyskinesia

Intervention

SD-809

Study Arms / Comparison Groups

 SD-809

Description:  SD-809 tablets taken twice daily for 12 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

117

Start Date

June 2014

Completion Date

May 2015

Primary Completion Date

May 2015

Eligibility Criteria

        Inclusion Criteria:

          -  History of using a dopamine receptor antagonist for at least 3 months

          -  Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months
             prior to screening

          -  Subjects with underlying psychiatric diagnosis are stable and have no change in
             psychoactive medications

          -  Have a mental health provider and does not anticipate any changes to treatment regimen
             in the next 3 months

          -  History of being compliant with prescribed medications

          -  Able to swallow study drug whole

          -  Be in good general health and is expected to attend all study visits and complete
             study assessments

          -  Female subjects must not be pregnant and agree to an acceptable method of
             contraception

        Exclusion Criteria:

          -  Currently receiving medication for the treatment of tardive dyskinesia

          -  Have a neurological condition other than tardive dyskinesia that may interfere with
             assessing the severity of dyskinesias

          -  Have a serious untreated or undertreated psychiatric illness

          -  Have recent history or presence of violent behavior

          -  Have unstable or serious medical illness

          -  Have evidence of hepatic impairment

          -  Have evidence of renal impairment

          -  Have known allergy to any component of SD-809 or tetrabenazine

          -  Has participated in an investigational drug or device trial and received study drug
             within 30 days

          -  Have acknowledged use of illicit drugs

          -  Have a history of alcohol or substance abuse in the previous 12 months
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Teva Medical Expert, M.D., , 

Location Countries

Czechia

Location Countries

Czechia

NCT ID

NCT02195700

Organization ID

SD-809-C-18

Responsible Party

Sponsor

Study Sponsor

Auspex Pharmaceuticals, Inc.

Study Sponsor

Teva Medical Expert, M.D., Study Director, Teva Branded Pharmaceutical Products R&D, Inc.

Verification Date

November 2021