Effects of CX516 on Functioning in Fragile X Syndrome and Autism

This study has been completed.

Sponsor:

Collaborator:

FRAXA Foundation

Information provided by:

Cortex Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00054730

First received: February 7, 2003

Last updated: June 23, 2005

Last verified: February 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	February 7, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	June 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00054730 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Official Title ^ICMJE	Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Fragile X Syndrome Autism
Intervention ^ICMJE	Drug: CX516 (Ampalex®)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00054730
Other Study ID Numbers ^ICMJE	CORX-CX516-013
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Cortex Pharmaceuticals
Collaborators ^ICMJE	FRAXA Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	Cortex Pharmaceuticals
Verification Date	February 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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