A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)

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Brief Title

A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)

Official Title

A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome

Brief Summary

      The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of
      SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the
      pharmacokinetic of SD-809 and its metabolites.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety

Secondary Outcome

 Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)

Condition

TOURETTE SYNDROME

Intervention

SD-809

Study Arms / Comparison Groups

 SD-809
Description:  • SD-809 tablets taken once or twice daily for 8 weeks, includes a dose titration period and a maintenance period.

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

23

Start Date

July 2014

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility Criteria

        Inclusion Criteria:

          -  12 to 18 years of age, inclusive, at Screening.

          -  Patient has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
             (DSM-V) diagnosis of Tourette Syndrome and has manifested motor and phonic tics within
             3 months before the Screening visit

          -  Patient has total tic score of ≥19 on the YGTSS

          -  Tic severity and frequency has been stable for at least 2 weeks before the Screening
             visit

          -  Willing to adhere to medication regimen and to comply with all procedures

          -  Patient is in good general health, as indicated by medical and psychiatric history and
             physical examination

          -  Patient and parent/guardian have provided written, informed consent (and written
             assent, as appropriate)

          -  Female patients of childbearing potential agree to use an acceptable method of
             contraception

               -  Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Patient has a serious untreated or undertreated psychiatric illness

          -  Patient has a history of suicidal ideation or behavior

          -  Patient has received tetrabenazine, neuroleptics, benzodiazepines, topiramate,
             dopamine receptor antagonists within 14 days of Screening or Baseline; or botulinum
             toxin within 3 months of Screening or Baseline

          -  Patient is being treated with deep brain stimulation for control of tics

          -  Patient has a progressive or degenerative neurological disorder or a structural
             disorder of the brain

          -  Patient has participated in an investigational drug or device trial within 30 days of
             Screening

          -  Patient is pregnant or breastfeeding at Screening or Baseline

          -  Patient has a history of alcohol or substance abuse in the previous 12 months, as
             defined in the DSM-V

               -  Additional criteria apply, please contact the investigator for more information
      

Gender

All

Ages

12 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Teva Medical Expert, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02674321

Organization ID

SD-809-C-17


Responsible Party

Sponsor

Study Sponsor

Auspex Pharmaceuticals, Inc.


Study Sponsor

Teva Medical Expert, MD, Study Director, Teva Pharmaceuticals USA


Verification Date

February 2016