Effects of CX516 on Functioning in Fragile X Syndrome and Autism

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00054730
• Date of registration: 07/02/2003
• Prospective Registration: No
• Primary sponsor: Cortex Pharmaceuticals
• Public title: Effects of CX516 on Functioning in Fragile X Syndrome and Autism
• Scientific title: Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism
• Date of first enrolment: June 2002
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00054730
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Autism

Fragile X Syndrome

Intervention(s)

Drug: CX516 (Ampalex®)

Secondary ID(s)

CORX-CX516-013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FRAXA Foundation