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Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

NCT00846547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-06-14

Study results available
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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.

Conditions

  • Autism Spectrum Disorders

Interventions

DRUG

Arbaclofen

variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period

Sponsors & Collaborators

  • Seaside Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Lawrence Scahill, PhD · Yale University

  • Craig Erikson, MD · Riley Hospital for Children

  • Bryan King, MD, PhD · Seattle Children's Hospital

  • James McCracken, MD · University of California, Los Angeles

  • Linmarie Sikich, MD · University of North Carolina Neurosciences Hospital

  • Jeremy Veenstra-VanderWeele, MD · Vanderbilt Kennedy Center

  • Lawrence Ginsberg, MD · Red Oaks Psychiatry Associates, PA

  • Raun Melmed, MD · Southwest Autism Research & Resource Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846547 on ClinicalTrials.gov