Trial | NCT00054730  Report issue

Title

Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ampalex ...

  • Study Participants

    None
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.
Study Started
Jun 30
2002
Last Update
Jun 24
2005
Estimate

Drug CX516 (Ampalex®)

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
No Results Posted