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Home > "E" Clinical Trials Conditions > Effects of CX516 on Functioning in Fragile X Syndrome and Autism  Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Effects of CX516 on Functioning in Fragile X Syndrome and Autism
For Condition: Fragile X Syndrome,Autism
Status: Recruiting
Sponsor(s): Cortex Pharmaceuticals , FRAXA Foundation
Synopsis: This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism. CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is evidence to suggest that the synapses in the brain of an individual with fragile X syndrome are immature and abnormal. It is possible CX516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning. There is also reason to believe that these changes caused by CX516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder. Involvement for each participant will last 28 days. Participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: Fragile X group - DNA-based diagnosis of Fragile X syndrome Autism group - Documented diagnosis with ADOS; ADI-R; CARS and GARS Both groups - 18-50 years - Measured IQ below 85 - Measured IQ >20 - Mental age >30 months - Stable medication regimen for past 8 weeks - Normal hearing - Vision corrected to at least 20/50 - All females of childbearing age must have a negative pregnancy test at enrollment Exclusion criteria: - Recent history of seizure, epilepsy, or blackouts - Unresolved medical issue impacting performance - Behavioral dysfunction to the point that subject cannot cooperate for testing - History of drug-induced neutropenia - Uncontrolled hypertension
Total Enrollment:
Location and Contact Information:
UC Davis-MIND Institute *Not yet recruiting*
Sacramento, California, 95817
United States
Not yet recruiting Randi Hagerman 916-734-6348
RUSH-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Elizabeth Berry-Kravis 312-942-4036
Additional Information:
Study ID Numbers: CORX-CX516-013;
Study Start Date: June 2002
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054730
Other Fragile X Syndrome Studies:
1. Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Related Studies:
Other Fragile X Syndrome Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Effects of CX516 on Functioning in Fragile X Syndrome and Autism
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