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

NCT00846547 | Completed Phase 2 Results DMC

• 1 other identifier: 22003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

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.

Conditions

Autism Spectrum Disorders

Keywords

Autism; Autism Spectrum Disorders; irritability; aberrant behavior

Outcome Measures

Primary Outcomes (1)

• Irritability Subscale of the Aberrant Behavior Checklist, Community Version

  The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).

  At 8 weeks during the treatment period

Study Arms (1)

Arbaclofen

EXPERIMENTAL

Drug: Arbaclofen

Interventions

Arbaclofen DRUG

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

Also known as: STX209

Arbaclofen

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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, PA

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

Results Point of Contact

• Title: Dr. Paul Wang, Vice President of Clinical and Medical Affairs
• Organization: Seaside Therapeutics

pwang@seasidetherapeutics.com

617-374-9009

Study Officials

• Lawrence Scahill, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Craig Erikson, MD

  Riley Hospital for Children

  PRINCIPAL INVESTIGATOR

• Bryan King, MD, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• James McCracken, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Linmarie Sikich, MD

  University of North Carolina Neurosciences Hospital

  PRINCIPAL INVESTIGATOR

• Jeremy Veenstra-VanderWeele, MD

  Vanderbilt Kennedy Center

  PRINCIPAL INVESTIGATOR

• Lawrence Ginsberg, MD

  Red Oaks Psychiatry Associates, PA

  PRINCIPAL INVESTIGATOR

• Raun Melmed, MD

  Southwest Autism Research & Resource Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 17, 2009
• First Posted: February 18, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 14, 2013
• Results First Posted: June 14, 2013

Record last verified: 2013-05

Locations

US (8)