Clinical trial NCT00846547: Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
Official title: An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorders
Keywords: Autism
Autism Spectrum Disorders
irritability
aberrant behavior
Lead sponsor: Seaside Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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. We hypothesize that STX209 will be safe and well-tolerated.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 6 to 17 years of age, inclusive.
* Diagnosis of Autistic spectrum disorders
* Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate or higher at screening and at Visit 1 (Day 1).
* An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening and at Visit 1 (Day 1).
* If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 3 months prior to Screening (Visit 1) and subjects and their parent/caregiver/legally authorized representative (LAR) will not electively initiate new or modify ongoing interventions for the duration of the study.
* Exclusion Criteria:
* Subjects with known genetic disorders associated with PDD such as fragile X syndrome.
* Subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication.
* Subjects with any medical condition, including alcohol and drug abuse that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks.
* Subjects currently treated with vigabatrin or tiagabine.
* Subjects taking another investigational drug currently or within the last 30 days.
* Subjects who have a history of hypersensitivity to racemic baclofen.

Primary outcomes:
measure: Irritability Subscale of the Aberrant Behavior Checklist, Community Version
timeFrame: At 8 weeks during the treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research & Resource Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California-Los Angeles Neuropsychiatric Institute
state: California
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina Neurosciences Hospital
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt Kennedy Center
state: Tennessee
city: Houston
country: United States
facility: Red Oaks Psychiatry Associates, PA
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Yale University
name: Lawrence Scahill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riley Hospital for Children
name: Craig Erikson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Bryan King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: James McCracken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina Neurosciences Hospital
name: Linmarie Sikich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Kennedy Center
name: Jeremy Veenstra-VanderWeele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Red Oaks Psychiatry Associates, PA
name: Lawrence Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Autism Research & Resource Center
name: Raun Melmed, MD
role: PRINCIPAL_INVESTIGATOR
References: