Effects of CX516 on Functioning in Fragile X Syndrome and Autism
NCT ID: NCT00054730
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2002-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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CX516 (Ampalex®)
Eligibility Criteria
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Inclusion Criteria
* 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
* Unresolved medical issue impacting performance
* Behavioral dysfunction to the point that subject cannot cooperate for testing
* History of drug-induced neutropenia
* Uncontrolled hypertension
18 Years
50 Years
ALL
No
Sponsors
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FRAXA Research Foundation
OTHER
RespireRx
INDUSTRY
Locations
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UC Davis-MIND Institute
Sacramento, California, United States
RUSH-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Countries
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Related Links
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Fraxa is a research foundation whose mission is to support research aimed at treatment for Fragile X syndrome.
Other Identifiers
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CORX-CX516-013
Identifier Type: -
Identifier Source: org_study_id