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

Study Overview
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Brief Summary
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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.

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

Conditions
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TOURETTE SYNDROME

Intervention / Treatment
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* Drug: SD-809


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourette Syndrome, adolescents