Autism Spectrum DisordersPhase 2NCT01288716
Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
A Phase 2 study testing Arbaclofen in people with Autism Spectrum Disorders, run by Seaside Therapeutics, Inc. at 24 sites in United States.
Trial summary
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Arbaclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 24 sitesUnited States
- Study dates
- May 2011to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Autism Spectrum Disorders (ASD)
- Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
- Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
- 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 2 months prior to Screening
Who cannot join
- Subjects with any condition, including alcohol and drug abuse, which 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 who have taken another investigational drug within the last 30 days.
- Subjects who are not able to take oral medications
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Akron Children's Hospital
Akron, Ohio, 44308
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Boston Children's Hospital
Boston, Massachusetts, 02115
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, 27514
Institute for Juvenile Research
Chicago, Illinois, 60608
University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders
Columbia, Missouri, 65211
Red Oaks Psychiatry Associates, P.A.
Houston, Texas, 77090
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, 90024
Suburban Research Associates
Media, Pennsylvania, 19063
University of Tennessee Medical Group, LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Pharmax Research Clinic
Miami, Florida, 33126
Vanderbilt Kennedy Center
Nashville, Tennessee, 37203
Seaver Autism Center, Mount Sinai Medical Center
New York, New York, 10029
Cutting Edge Research
Oklahoma City, Oklahoma, 73116
Lake Mary Pediatrics
Orange City, Florida, 32763
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006
Summit Research Network
Portland, Oregon, 97210
University of California-Davis, M.I.N.D. Institute
Sacramento, California, 95817
Road Runner Research
San Antonio, Texas, 78258
Seattle Children's Hospital
Seattle, Washington, 98101
Institute for Behavioral Medicine
Smyrna, Georgia, 30080
University of Massachusetts
Worcester, Massachusetts, 01605
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders
- Conditions
- Autism Spectrum Disorders
- Being tested
- Arbaclofen
- Keywords
- ASD, Autism, Asperger Syndrome
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArbaclofenDrug
Also called STX209, R-baclofen
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described |
| Arbaclofen | Active comparator | Not described Receives: Drug: Arbaclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist-Social Withdrawal Subscale
Measured: At 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seaside Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288716
- Sponsor's protocol ID
- 209AS208
- Status last verified
- Jul 2013
- First submitted
- 31 Jan 2011
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01288716
- Acronym / sponsor ID
- 209AS208
- Conditions
- Autism Spectrum Disorders
- Keywords
- ASD, Autism, Asperger Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seaside Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | – |
| Arbaclofen | Active comparator | Drug: Arbaclofen |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of Autism Spectrum Disorders (ASD)
- Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
- Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
- 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 2 months prior to Screening
Key exclusion criteria (4 listed)
- Subjects with any condition, including alcohol and drug abuse, which 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 who have taken another investigational drug within the last 30 days.
- Subjects who are not able to take oral medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArbaclofenAlso: STX209, R-baclofen | Drug | Arbaclofen |
Primary outcome
Aberrant Behavior Checklist-Social Withdrawal Subscale
Time frame: At 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arbaclofen in people with Autism Spectrum Disorders, run by Seaside Therapeutics, Inc. at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist-Social Withdrawal Subscale (time frame: At 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.