Clinical trial NCT02674321: A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)
Official title: A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: TOURETTE SYNDROME
Keywords: Tourette Syndrome
adolescents
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 23
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline, Weeks 2, 4 and 8
measure: Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline, Weeks 2, 4, and 8
measure: Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline, Weeks 2, 4, and 8
measure: Change from Baseline in Tourette Syndrome Clinical Global Impression
timeFrame: Baseline, Weeks 2, 4, and 8
measure: Patient Global Impression of Change (TS-PGIC)
timeFrame: Weeks 2, 4, and 8
Other outcomes:
measure: Pharmacokinetic parameters
timeFrame: 8 weeks
Locations:
city: Houston
country: United States
facility: Teva Investigational Site #101
state: Texas
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: