Effects of CX516 on Functioning in Fragile X Syndrome and Autism

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054730
• Other study ID #: CORX-CX516-013
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2003
• Last updated: June 23, 2005
• Start date: June 2002

Study information

• Verified date: February 2005
• Source: RespireRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Fragile X Syndrome
• Syndrome

Intervention

Drug:
• CX516 (Ampalex®)

Locations

Country	Name	City	State
United States	RUSH-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	UC Davis-MIND Institute	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
RespireRx	FRAXA Research Foundation

Country where clinical trial is conducted

United States, 

External Links

•   Fraxa is a research foundation whose mission is to support research aimed at treatment for Fragile X syndrome.