Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334419
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-08
Brief Title:
Placebo-Controlled Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome FXS
Sponsor:
Craig Erickson
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Placebo-Controlled Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome FXS
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a single dose placebo-controlled study Male subjects aged 18 to 40 years inclusive with a diagnosis of FXS Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart for a total of four visits Subjects will be given single dose gaboxadol 10 mg or matched placebo at each of these visits to take orally Thus all enrolled subjects will receive placebo at home and in clinic and receive gaboxadol at home and in clinic in a blinded fashion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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