Reducing Involuntary Movements in Tardive Dyskinesia

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Brief Title

Reducing Involuntary Movements in Participants With Tardive Dyskinesia

Official Title

An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Brief Summary

      The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
      SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe
      tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809
      following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks
      of maintenance with SD-809.
    

Detailed Description

      Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any
      other SD-809 study will be enrolled in this study. This study include a screening period
      (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind,
      randomized withdrawal period (Part B), treatment after completion of the randomized
      withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Part A and B: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal

Secondary Outcome

 Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating

Condition

Tardive Dyskinesia

Intervention

SD-809

Study Arms / Comparison Groups

 Part A: SD-809
Description:  Participants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158.

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

343

Start Date

October 20, 2014

Completion Date

December 14, 2020

Primary Completion Date

December 6, 2019

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

          -  Participant has successfully completed a controlled study of SD-809 for treatment of
             moderate to severe tardive dyskinesia

          -  Participants 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 participants 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 (other than Study C-18,
             Study C-23, or any other eligible TEV-50717 parent study) 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 - N/A

Accepts Healthy Volunteers

No

Contacts

Teva Medical Expert, M.D., , 

Location Countries

Czechia

Location Countries

Czechia

Administrative Informations


NCT ID

NCT02198794

Organization ID

SD-809-C-20

Secondary IDs

2014-001891-73

Responsible Party

Sponsor

Study Sponsor

Auspex Pharmaceuticals, Inc.


Study Sponsor

Teva Medical Expert, M.D., Study Director, Teva Pharmaceuticals USA


Verification Date

February 2021