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

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

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 Overview

• Status: Completed
• Conditions: TOURETTE SYNDROME
• Intervention / Treatment: Drug: SD-809

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Teva Investigational Site #101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SD-809; • SD-809 tablets taken once or twice daily for 8 weeks, includes a dose titration period and a maintenance period.	Drug: SD-809

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)	Baseline, Weeks 2, 4 and 8
Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS)	Baseline, Weeks 2, 4, and 8
Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS)	Baseline, Weeks 2, 4, and 8
Change from Baseline in Tourette Syndrome Clinical Global Impression	Baseline, Weeks 2, 4, and 8
Patient Global Impression of Change (TS-PGIC)	Weeks 2, 4, and 8

Other Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters	8 weeks

Collaborators and Investigators

• Sponsor: Auspex Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: adolescents; Tourette Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: SD-809-C-17