Autism Spectrum DisordersPhase 3NCT01706523
Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
A Phase 3 study testing STX209 (arbaclofen) in people with Autism Spectrum Disorders, run by Seaside Therapeutics, Inc. at 25 sites in United States.
Trial summary
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD. 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?
- STX209 (arbaclofen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 25 sitesUnited States
- Study dates
- Nov 2011to Jul 2013
- Phase
- Phase 3
- 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
- Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.
- Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.
- Treatment with no more than 2 psychoactive medications
- Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol
- For female subjects, negative pregnancy test
Who cannot join
- Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.
- Current use of illicit drugs or alcohol abuse.
- Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator
- Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Akron Children's Hospital
Akron, Ohio, 44308
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Boston Children's Hospital
Boston, Massachusetts, 02115
UNC Chapel Hill Department of Psychiatry
Chapel Hill, North Carolina, 27514
Institute for Juvenile Research
Chicago, Illinois, 60608
University of Missouri, Thompson Research Center for Autism & Neurodevelopmental 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
UCDavis M.I.N.D Insitute
Sacramento, California, 95817
Road Runner Research
San Antonio, Texas, 78258
Seattle Children's Hospital
Seattle, Washington, 98101
Institute for Behavioral Medicine
Smyrna, Georgia, 30080
NYS Institute for Basic Research in Developmental Disabilities
Staten Island, New York, 10314
University of Massachusetts
Worcester, Massachusetts, 01605
About this study
Official title: An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
Read the detailed description
This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.
Protocol 209AS208, "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."
Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."
This open-label extension will provide data on the following:
- Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
- Provide supporting pharmacokinetic analyses
- Assess long term efficacy on social behaviors in subjects with ASD.
- Conditions
- Autism Spectrum Disorders
- Being tested
- STX209 (arbaclofen)
- Keywords
- Autism Spectrum Disorders, Autism, Asperger, Pervasive Developmental Disorder - Not otherwise specified
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STX209 (arbaclofen)Drug
Long-term, daily, orally-administered STX209
| Study group | Role | What they receive |
|---|---|---|
| STX209 | Experimental | Active treatment with STX209 Receives: Drug: STX209 (arbaclofen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of STX209
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
Measured: 100 weeks
Secondary outcomes (1)
Aberrant Behavior Checklist
Open-label assessment of change from baseline on the ABC
Measured: 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJul 2013 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seaside Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Wang, M.D., Study director, Seaside Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706523
- Sponsor's protocol ID
- 209AS209
- Status last verified
- Jul 2013
- First submitted
- 10 Oct 2012
- 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
- An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01706523
- Acronym / sponsor ID
- 209AS209
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorders, Autism, Asperger, Pervasive Developmental Disorder - Not otherwise specified
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Seaside Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (estimated)
- First posted
- 15 Oct 2012 (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.
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
Detailed description
This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.
Protocol 209AS208, "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."
Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."
This open-label extension will provide data on the following:
- Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
- Provide supporting pharmacokinetic analyses
- Assess long term efficacy on social behaviors in subjects with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STX209 | Experimental | Drug: STX209 (arbaclofen)Active treatment with STX209 |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.
- Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.
- Treatment with no more than 2 psychoactive medications
- Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol
- For female subjects, negative pregnancy test
Key exclusion criteria (4 listed)
- Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.
- Current use of illicit drugs or alcohol abuse.
- Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator
- Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole
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 |
|---|---|---|
| STX209 (arbaclofen)Long-term, daily, orally-administered STX209 | Drug | STX209 |
Primary outcome
Safety and tolerability of STX209
Time frame: 100 weeks
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
1 secondary outcome
Aberrant Behavior Checklist
Time frame: 100 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
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.
Paul Wang, M.D. study director
Seaside Therapeutics, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STX209 (arbaclofen) in people with Autism Spectrum Disorders, run by Seaside Therapeutics, Inc. at 25 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 5 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: stopped early, 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 25 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Safety and tolerability of STX209 (time frame: 100 weeks). 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.