- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00054730
Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Effects of Ampakine CX516 (Ampalex®) 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- UC Davis-MIND Institute
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Mental Retardation, X-Linked
- Intellectual Disability
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Chromosome Disorders
- Sex Chromosome Disorders
- Autism Spectrum Disorder
- Syndrome
- Autistic Disorder
- Fragile X Syndrome
Other Study ID Numbers
- CORX-CX516-013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fragile X Syndrome
-
University of California, DavisNational Institute of Mental Health (NIMH)CompletedFragile X PremutationUnited States
-
University of California, DavisNational Institute on Aging (NIA); Forest LaboratoriesCompletedFragile X-Associated Tremor/Ataxia Syndrome | Fragile X Premutation CarriersUnited States
-
Ovid Therapeutics Inc.CompletedFragile X Syndrome (FXS)United States
-
Guido A. Davidzon, MD, SMWithdrawn
-
Marinus PharmaceuticalsUniversity of California, Davis; U.S. Army Medical Research and Development...Completed
-
RTI InternationalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedFragile X Syndrome (FXS)United States
-
Novartis PharmaceuticalsTerminated
-
Sheba Medical CenterElMindA LtdRecruitingFragile X Associated Tremor-ataxia Syndrome | FXTASIsrael
-
University of California, DavisUniversity of Alberta; St. Justine's HospitalRecruitingNeurobehavioral Manifestations | Genetic Diseases, X-Linked | Intellectual Disability | Fragile X Syndrome | Sex Chromosome Disorders | Fragile X Mental Retardation Syndrome | Trinucleotide Repeat Expansion | Fra(X) Syndrome | FXS | Mental Retardation, X LinkedUnited States, Canada
-
University of AlbertaSt. Justine's HospitalRecruitingNeurobehavioral Manifestations | Genetic Diseases, X-Linked | Mental Retardation, X-Linked | Intellectual Disability | Fragile X Syndrome | Sex Chromosome Disorders | Fragile X Mental Retardation Syndrome | Trinucleotide Repeat Expansion | Fra(X) Syndrome | FXSCanada
Clinical Trials on CX516 (Ampalex®)
-
National Institute of Neurological Disorders and...Completed
-
RespireRxCompletedMild Cognitive ImpairmentUnited States
-
North Suffolk Mental Health AssociationRespireRxCompletedSchizophreniaUnited States
-
Dong-A ST Co., Ltd.CompletedFunctional DyspepsiaKorea, Republic of
-
Galderma R&DCompletedAtopic DermatitisPhilippines, China
-
Chong Kun Dang PharmaceuticalCompleted
-
Chung-Ang University Hosptial, Chung-Ang University...UnknownFunctional DyspepsiaKorea, Republic of
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Diphtheria | PolioUnited States
-
Amir AzarpazhoohInstitut Straumann AGCompletedPeriodontal Inflammation | Crown LengtheningCanada
-
Novartis PharmaceuticalsCompletedPulmonary Disease, Chronic Obstructive (COPD)Argentina