Status:
COMPLETED
Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome
Lead Sponsor:
Seaside Therapeutics, Inc.
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
6-40 years
Phase:
PHASE2
Brief Summary
The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typ...
Eligibility Criteria
Inclusion
- Male or female subjects 12 to 40 years of age eventually expanding to 6 years of age
- Molecular documentation of the fragile X mutation.
- Clinical Global Impression - Severity (CGI-S) rating for problem behavior of moderate or higher at screening and at Visit 1
- An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score \>12 and at least 3 items on the Irritability Subscale rated at least moderate or above.
- Current treatment with no more than three psychoactive medications, including anti-epileptics.
- Current pharmacological treatment regimen has been stable for at least 4 weeks.
Exclusion
- Subjects with a history of seizure disorder who are not currently receiving treatment with antiepileptics.
- 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. This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
- Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
- Subjects who are currently receiving treatment with racemic baclofen.
- Subjects currently treated with vigabatrin or tiagabine.
- Subjects taking another investigational drug currently or within the last 30 days.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00788073
Start Date
November 1 2008
End Date
May 1 2010
Last Update
May 6 2013
Active Locations (12)
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1
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States, 85006
2
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States, 90024
3
M.I.N.D. Institute
Sacramento, California, United States, 95817
4
Rush University Medical Center
Chicago, Illinois, United States, 60612