Working… Menu

Effects of CX516 on Functioning in Fragile X Syndrome and Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054730
Recruitment Status : Completed
First Posted : February 11, 2003
Last Update Posted : June 24, 2005
FRAXA Research Foundation
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Fragile X Syndrome Autism Drug: CX516 (Ampalex®) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism
Study Start Date : June 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054730

Layout table for location information
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
FRAXA Research Foundation

Additional Information:
Layout table for additonal information Identifier: NCT00054730     History of Changes
Other Study ID Numbers: CORX-CX516-013
First Posted: February 11, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2005
Keywords provided by RespireRx:
Fragile X Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Fragile X Syndrome
Autistic Disorder
Pathologic Processes
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Mental Retardation, X-Linked
Intellectual Disability
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