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Effects of CX516 on Functioning in Fragile X Syndrome and Autism

This study has been completed.
FRAXA Foundation
Information provided by:
Cortex Pharmaceuticals Identifier:
First received: February 7, 2003
Last updated: June 23, 2005
Last verified: February 2005

February 7, 2003
June 23, 2005
June 2002
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Complete list of historical versions of study NCT00054730 on Archive Site
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Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism

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.

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Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Fragile X Syndrome
  • Autism
Drug: CX516 (Ampalex®)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
18 Years to 50 Years
Contact information is only displayed when the study is recruiting subjects
United States
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Cortex Pharmaceuticals
FRAXA Foundation
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Cortex Pharmaceuticals
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP