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

A

Auspex Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

TOURETTE SYNDROME

Treatments

Drug: SD-809

Study type

Interventional

Funder types

Industry

Identifiers

NCT02674321
SD-809-C-17

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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