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

NCT02674321 | Completed Phase 1

• 1 other identifier: SD-809-C-17
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety

  Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.

  8 weeks

Secondary Outcomes (5)

• 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 Outcomes (1)

• Pharmacokinetic parameters

  8 weeks

Study Arms (1)

SD-809

EXPERIMENTAL

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

Drug: SD-809

Interventions

SD-809 DRUG

SD-809

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Auspex Pharmaceuticals, Inc.: lead

Study Sites (1)

Teva Investigational Site #101

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

deutetrabenazine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 4, 2016
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

US (1)