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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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7 October 2014 |
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Main ID: |
EUCTR2008-003287-18-BE |
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Date of registration:
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03/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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17/09/2008 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003287-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: control group without Fragile X
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Controls:
Males between 18-50 years old, general good health after physical examination and routine laboratory analysis, normal T1 and T2 brain MRI, body weight.
Patients:
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.
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
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Health Condition(s) or Problem(s) studied
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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.
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Intervention(s)
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Product Name: 11C-flumazenil
Pharmaceutical Form: Injection*
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Primary Outcome(s)
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Primary end point(s): 1/ Image quantification of GABA-A receptor binding in Fragile X patients versus controls
2/ relationship of any clinical abnormality to (decreased) GABA-A receptor binding
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Main Objective: It is our aim to investigate the functional consequences of our previous findings from animal studies, i.e. the physiological consequences of decreased expression of specific GABA(A)receptor subunits. Using Positron Emission Tomography (PET) with [11C]flumazenil we want to image and quantify the GABA(A)receptor distribution in fragile X patients and compare this with controls.
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Secondary Objective: Using a battery of tests such as 24h EEG control, movement analysis, neuropsychological tests and a MRI scan, we would like to measure neuropsychologic (cognitive impairment, executive functioning) and behavioural (gait ataxia, action tremor, parkinsonism, neuropathy, autonomic failure..) parameters to investigate a behavioural correlaton of the regional PET GABA(A)receptor findings between patients and controls.
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Secondary ID(s)
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PET-FRAX-001
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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