Effects of CX516 on Functioning in Fragile X Syndrome and Autism

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00054730

Enrollment

Unknown

Registered

2003-02-11

Start date

2002-06-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Fragile X Syndrome

Keywords

Fragile X Syndrome, Autism

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.

Interventions

DRUGCX516 (Ampalex®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026