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

NCT ID: NCT01064973

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorders

Keywords

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autism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STX209

STX209 (arbaclofen)

Group Type EXPERIMENTAL

arbaclofen

Intervention Type 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

Interventions

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arbaclofen

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

Intervention Type DRUG

Other Intervention Names

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R-baclofen, STX209, arbaclofen

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seaside Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southwest Autism Research & Resource Center

Phoenix, Arizona, United States

Site Status

University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California, United States

Site Status

Yale Child Study Center

New Haven, Connecticut, United States

Site Status

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

University of North Carolina Neurosciences Hospital

Chapel Hill, North Carolina, United States

Site Status

Vanderbilt Kennedy Center

Nashville, Tennessee, United States

Site Status

Red Oaks Psychiatry Associates, P.A.

Houston, Texas, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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22007

Identifier Type: -

Identifier Source: org_study_id