An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

Phase 2TerminatedNCT01064973

Seaside Therapeutics, Inc.32 enrolled

Overview

Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with ASD who receive treatment under conditions more closely reflective of their general medical care.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autism Spectrum Disorders

Interventions

A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the oral OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have completed all scheduled visits in protocol 22003 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator Exclusion Criteria: * Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * The occurrence or continuation of any adverse event or condition during study 22003 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension

Locations (8)

Southwest Autism Research & Resource Center

Phoenix, Arizona, United States

University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California, United States

Yale Child Study Center

New Haven, Connecticut, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

University of North Carolina Neurosciences Hospital

Chapel Hill, North Carolina, United States

Vanderbilt Kennedy Center

Nashville, Tennessee, United States

Red Oaks Psychiatry Associates, P.A.

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States