Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism
Trial Title: Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
Identified Contact Person:
Name: Gina Murfree
Title: Study Coordinator
Phone: (615) 653-3782
Email: gina.murfree@Vanderbilt.edu
Facility/Institution: Vanderbilt
Department: Kennedy Center
City, State, Zip: Nashville, TN 37232
Principal Investigator’s Contact Information:
Name: Jeremy Veenstra-VanderWeele, MD
Title: Child and Adolescent Psychiatrist
Phone: 615-936-1701
Email: jeremy.veenstra-vanderweele@vanderbilt.edu
Facility/Institution: Vanderbilt
Department: Kennedy Center
City, State, Zip: Nashville, TN 37232
Brief Summary of Study’s Purpose:
The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability.
Study Type: Interventional
Trial Sponsor(s): Seaside Therapeutics
Study Phase (if applicable): Phase II
Unique trial identification number: NCT00846547
Location(s) where study is being conducted:
Include for each location:
Facility: Vanderbilt Kennedy Center
Contact person: Gina Murfree
Phone (615): 653-3782
Email addresses gina.murfree@Vanderbilt.edu
URL where study information can be found: http://www.clinicaltrials.gov/ct2/show/NCT00846547?term=seaside+autism&rank=1
Eligibility Criteria:
a. Inclusion criteria: Children and Adolescents agers 6 through 17 years with Autism Spectrum Disorders including Autism and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
b. Exclusion criteria: Children and adolscents with known genetic disorders associated with PDD such as fragile X syndrome. Children and adolescents who have a history of seizures but are not on anti-epileptic medication. Children and adolescents cannot be included if they have a significant, unstable medical condition
c. Gender: Both
d. Minimum age: 6
e. Maximum age: 17
Number of Participants Needed: 30 for the entire study
Start Date of Recruiting: March 2009
Closure Date: September 2009
Time Commitment Length: Up to 18 weeks (4.5 months)
Time Commitment Frequency: 7 in-person visits, roughly every two weeks; 17 telephone calls every 3-4 days.
List your IRB study/protocol approval number. IRB #080998
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