Effects of CX516 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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Key information

Conditions

Fragile X Syndrome Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Sex Chromosome Disorders X-Linked Intellectual Disability

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UC Davis-MIND Institute, Sacramento, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CX516 (Ampalex®)

Drug

Sponsors and collaborators

Lead sponsor

RespireRx

Industry

Collaborators

FRAXA Research Foundation

Registry information

Official study title

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

Important dates

Study start: 2002
First posted: Feb 11, 2003
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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