NCT00054730

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2003

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 2005

First QC Date

February 7, 2003

Last Update Submit

June 23, 2005

Conditions

Fragile X SyndromeAutism

Keywords

Fragile X SyndromeAutism

Interventions

CX516 (Ampalex®)DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fragile X group
  • DNA-based diagnosis of Fragile X syndrome
  • Autism group
  • Documented diagnosis with ADOS; ADI-R; CARS and GARS
  • Both groups
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC Davis-MIND Institute

Sacramento, California, 95817, United States

Location

RUSH-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Related Links

MeSH Terms

Conditions

Fragile X SyndromeAutistic Disorder

Interventions

1-(quinoxalin-6-ylcarbonyl)piperidine

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGenetic Diseases, X-LinkedHeredodegenerative Disorders, Nervous SystemAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2003

First Posted

February 11, 2003

Study Start

June 1, 2002

Last Updated

June 24, 2005

Record last verified: 2005-02

Locations

US(2)