Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01706523|
Recruitment Status : Terminated
First Posted : October 15, 2012
Last Update Posted : July 31, 2013
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: STX209 (arbaclofen)||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
Active treatment with STX209
Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
- Safety and tolerability of STX209 [ Time Frame: 100 weeks ]Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
- Aberrant Behavior Checklist [ Time Frame: 100 weeks ]Open-label assessment of change from baseline on the ABC
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||5 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706523
|Study Director:||Paul Wang, M.D.||Seaside Therapeutics, Inc.|
|Responsible Party:||Seaside Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 15, 2012 Key Record Dates|
|Last Update Posted:||July 31, 2013|
|Last Verified:||July 2013|
Autism Spectrum Disorders
Pervasive Developmental Disorder - Not otherwise specified
Autism Spectrum Disorder
Child Development Disorders, Pervasive