Trials / Completed
CompletedNCT00846547
Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Seaside Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Arbaclofen | variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2010-06-01
- Completion
- 2010-09-01
- First posted
- 2009-02-18
- Last updated
- 2013-06-14
- Results posted
- 2013-06-14
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00846547. Inclusion in this directory is not an endorsement.