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Clinical Trials/EUCTR2008-003287-18-BE
EUCTR2008-003287-18-BE
Active, not recruiting
Not Applicable

Functional consequences of decreased RNA expression of certain GABA(A) receptor subunits in fragile X patients using Positron Emission Tomography and [11C]flumazenil. - PET-FRAX-GABA

niversity Antwerp0 sitesSeptember 3, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fragile X syndrome is the most common form of inherited mental retardation with a prevalence of 1/4000 males and 1/6000 females. Patients are characterized by a mild to severe form of cognitive impairment and light dysmorphic features. Autism-like behaviour, hyperactivity and epilepsy can also be associated with the disease. On the molecular level the disease is caused by a dynamic mutation of a CGG repeat in the 5' UTR of the FMR1 gene.
Sponsor
niversity Antwerp
Status
Active, not recruiting
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 3, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
niversity Antwerp

Eligibility Criteria

Inclusion Criteria

  • Males between 18\-50 years old, general good health after physical examination and routine laboratory analysis, normal T1 and T2 brain MRI, body weight.
  • Males between 16\-50 years old, need to be approved by the investigators to undergo a 60 minutes PET imaging study.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range
  • F.1\.3 Elderly (\>\=65 years) no
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • Controls and patients:
  • Drug abuse, hypersensitivity to drugs or flumazenil or benzodiazepines.
  • No history of other neurological or psychiatric abnormalities or any other major internal abnormality.
  • Medication which interacts with the GABA\-system, in particular sleep enhancing medication, is not allowed within two weeks before and after the study, neither
  • drinking more than 3 caffein\-containing glasses.
  • Current smokers (more than 5 sigarettes per day) and smokers who quitted less than three months ago will be excluded.
  • Alcohol is prohibited as from 2 days before the beginning of the study.

Outcomes

Primary Outcomes

Not specified

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