Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-01-26
Brief Title:
Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANAX
Brief Summary:
This study focuses on the therapeutic relevance of the endocannabinoid eCB system for the treatment of Fragile-X syndrome FXS the primary hereditary cause of autism spectrum disorder ASD Most individuals with FXS have moderate to severe intellectual disability ID and caregivers are mainly concerned about aggressive behavior and anxiety problems Since FXS individuals have a normal lifespan the overall lifetime cost for the Canadian society of a single case is estimated at 12 to 47 millions reaching 18 billions for all FXS cases There is no cure for FXS as all clinical trials so far have been unsuccessfulFXS is caused by transcriptional silencing of the Fragile X mental retardation protein FMR1 gene making FXS a simple model to study ASD and ID pathophysiological mechanisms Of those neuronal hyperexcitability is largely recognized as a core deficit in FXS and a critical therapeutic target for the disorder Using transcranial magnetic stimulation TMS in FXS patients our team provided the first direct evidence of Gamma-aminobutyric acid GABA receptor a GABAa dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability PMID 31748507 Concurrent lines of evidence suggest that stimulation of the endocannabinoid eCB system with the administration of Cannabidiol CBD could upregulate GABAergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS CBD has been shown to increase GABA concentration levels in the brains of healthy individuals an effect that could help correct the hyperexcitability typically found in FXS Thus this trial aims to define the therapeutic potential of the eCB system for FXS by measuring the impacts of oral CBD administration on the principal inhibitory neurotransmitter system of FXS patients and the severity of the clinical phenotype
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 275882 | OTHER | None | None |
| 202010PJT-451514 | OTHER_GRANT | Canadian Institutes of Health Research | None |