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

TOURETTE SYNDROME Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674321
• Other study ID #: SD-809-C-17
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• TOURETTE SYNDROME

Intervention

Drug:
• SD-809

Locations

Country	Name	City	State
United States	Teva Investigational Site #101	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Auspex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetic parameters		8 weeks
Primary	Safety	Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.	8 weeks
Secondary	Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)		Baseline, Weeks 2, 4 and 8
Secondary	Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS)		Baseline, Weeks 2, 4, and 8
Secondary	Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS)		Baseline, Weeks 2, 4, and 8
Secondary	Change from Baseline in Tourette Syndrome Clinical Global Impression		Baseline, Weeks 2, 4, and 8
Secondary	Patient Global Impression of Change (TS-PGIC)		Weeks 2, 4, and 8