Clinical Trials
A randomized, double-blind, placebo-controlled study of the efficacy, safety and tolerability of STX 209 (Arbaclofen) administered for the treatment of social withdrawal in children with Fragile X syndrome
The purpose of this study is to see how well a new medication, STX209 (Arbaclofen), works for the treatment of social withdrawal symptoms in individuals with Fragile X Syndrome. In earlier studies, this medication appears to be effective in individuals who exhibit behaviors such as being listless, sluggish or inactive, a preference for being alone and isolating themselves from others, being difficult to reach, contact or get through to and who have fixed facial expressions or a lack of emotions. The study includes several visits to the Thompson Center for physical examinations, ECG and blood draws as well as parent questionnaires over approximately 4 ½ months.Eligibility requirements:
- Children between the ages of 5 and 11 years of age
- Diagnosis of Fragile X Syndrome with symptoms of social withdrawal
- Time required: Approximately 1 hour every 2-4 weeks for 4 ½ months
- Location: Thompson Center, University of Missouri
- Compensation for time and travel
- Sponsored by Seaside Therapeutics
- Contact person: Deb Eichelberger, phone 573-882-4759, EichelbergerD@missouri.edu
- Research study director: David Beversdorf, M.D.
A randomized, double-blind, placebo-controlled study of the efficacy, safety and tolerability of STX 209 (Arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with Fragile X syndrome
The purpose of this study is to see how well a new medication, STX209 (Arbaclofen), works for the treatment of social withdrawal symptoms in individuals with Fragile X Syndrome. In earlier studies, this medication appears to be effective in individuals who exhibit behaviors such as being listless, sluggish or inactive, a preference for being alone and isolating themselves from others, being difficult to reach, contact or get through to and who have fixed facial expressions or a lack of emotions. The study includes several visits to the Thompson Center for physical examinations, ECG and blood draws as well as parent questionnaires over approximately 4 ½ months.Eligibility requirements:
- Adolescents and adults between the ages of 12 and 25 years of age
- Diagnosis of Fragile X Syndrome with symptoms of social withdrawal
- Time required: Approximately 1 hour every 2-4 weeks for 4 ½ months
- Location: Thompson Center, University of Missouri
- Compensation for time and travel
- Sponsored by Seaside Therapeutics
- Contact person: Deb Eichelberger, phone 573-882-4759, EichelbergerD@missouri.edu
- Research study director: David Beversdorf, M.D.
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