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

NCT ID: NCT02674321

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-06-30

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.

Conditions

TOURETTE SYNDROME

Keywords

Tourette Syndrome; adolescents

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SD-809

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

Group Type: EXPERIMENTAL

SD-809

Intervention Type: DRUG

Interventions

SD-809

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auspex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site #101

Houston, Texas, United States

Countries

United States

Other Identifiers

SD-809-C-17

Identifier Type: -

Identifier Source: org_study_id