- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770548
Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism (NMDA-Autism)
January 13, 2017 updated by: University Hospital, Tours
Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.
Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Analysis about 50 genes in glutamate synapse
Study Type
Interventional
Enrollment (Actual)
497
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brest, France, 29000
- CHRU - Centre de Ressources Autisme (CRA)
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Rouen, France, 76000
- CHS du Rouvray
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Tours, France, 37000
- Chru - Cic
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Tours, France, F-37000
- CHRU - Pédopsychiatrie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- have a Pervasive Developmental Disorder
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Autism
Analysis of the glutamate synapse in autism
|
Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
DNA collection
auditory evoked potentials
|
|
Other: Relative
Analysis of the glutamate synapse in autism
|
Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
DNA collection
auditory evoked potentials
|
|
Other: Major control
DNA collection
|
Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
DNA collection
auditory evoked potentials
|
|
Other: Minor control
auditory evoked potentials
|
auditory evoked potentials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
screening of about 50 genes encoding proteins of the NMDA receptor complex, chosen according to their chromosomal localisation located in hotspots depicted by genome-wide screens in large population of autistic patients
Time Frame: two years
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Frédérique BONNET-BRILHAULT, MD PHD, University François Rabelais of TOURS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 15, 2013
First Submitted That Met QC Criteria
January 16, 2013
First Posted (Estimate)
January 17, 2013
Study Record Updates
Last Update Posted (Estimate)
January 16, 2017
Last Update Submitted That Met QC Criteria
January 13, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AORT08-FBB/NMDA-Autism
- 2008-A01162-53 (Other Identifier: ID RCB)
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.
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