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

NCT01064973 | Terminated Phase 2

• 1 other identifier: 22007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Autism Spectrum Disorders

Keywords

autism

Outcome Measures

Primary Outcomes (1)

• Irritability subscale of the Aberrant Behavior Checklist

  every 2 to 3 months

Study Arms (1)

STX209

EXPERIMENTAL

STX209 (arbaclofen)

Drug: arbaclofen

Interventions

arbaclofen DRUG

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

Also known as: R-baclofen, STX209, arbaclofen

STX209

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seaside Therapeutics, Inc.: lead

Study Sites (8)

Southwest Autism Research & Resource Center

Phoenix, Arizona, 85006, United States

Location

University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California, 90024, United States

Location

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University of North Carolina Neurosciences Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Vanderbilt Kennedy Center

Nashville, Tennessee, 37203, United States

Location

Red Oaks Psychiatry Associates, P.A.

Houston, Texas, 77090, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

arbaclofen placarbil

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

US (8)