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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism

Resource links provided by NLM:

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
FRAXA Foundation
  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

No publications provided

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

Keywords provided by Cortex Pharmaceuticals:
Fragile X Syndrome
Autism

Additional relevant MeSH terms:
Autistic Disorder
Fragile X Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Mental Retardation, X-Linked
Mental Retardation
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System

ClinicalTrials.gov processed this record on May 23, 2013