Effects of CX516 on Functioning in Fragile X Syndrome and Autism

This study has been completed.

First Received: February 7, 2003 Last Updated: June 23, 2005 History of Changes

Sponsor:	Cortex Pharmaceuticals
Collaborator:	Fragile X Research Foundation of Canada
Information provided by:	Cortex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00054730

Purpose

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.

Condition	Intervention	Phase
Fragile X Syndrome Autism	Drug: CX516 (Ampalex®)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism

Resource links provided by NLM:

Genetics Home Reference related topics: fragile X syndrome L1 syndrome

MedlinePlus related topics: Autism Fragile X Syndrome

U.S. FDA Resources

Further study details as provided by Cortex Pharmaceuticals:

Study Start Date:

June 2002

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054730

Locations

United States, California
UC Davis-MIND Institute
Sacramento, California, United States, 95817
United States, Illinois
RUSH-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Cortex Pharmaceuticals

Fragile X Research Foundation of Canada

More Information

Additional Information:

Fraxa is a research foundation whose mission is to support research aimed at treatment for Fragile X syndrome. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CORX-CX516-013
Study First Received:	February 7, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00054730 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cortex Pharmaceuticals:

Fragile X Syndrome
Autism

Additional relevant MeSH terms:

Disease
Nervous System Diseases
Chromosome Disorders
Fragile X Syndrome
Child Development Disorders, Pervasive
Mental Retardation
Pathologic Processes
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Autistic Disorder

Mental Disorders
Syndrome
Mental Disorders Diagnosed in Childhood
Genetic Diseases, X-Linked
Neurologic Manifestations
Sex Chromosome Disorders
Congenital Abnormalities
Mental Retardation, X-Linked
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on November 11, 2009