Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413537
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-09
Brief Title:
Study of SPG601 in Adult Men With Fragile X Syndrome
Sponsor:
Spinogenix
Organization:
Spinogenix
Study Overview
Official Title:
A Phase 2a Randomized Double-Blinded Study Evaluating the Neurophysiologic vs Clinical Effects of Single-Dose SPG601 and Placebo in Adult Men With Fragile X Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
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 Phase 2 study described herein will evaluate the safety efficacy tolerability pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome
Detailed Description:
This study is a Phase 2 randomized double blind placebo-controlled cross over single dose of SPG601 and matching Placebo in patients with Fragile X syndrome
This study will entail 2 in person clinic visits to administer oral doses of SPG601 or matching placebo Participants will receive a dose of either SPG601 or placebo at first visit and will cross over to receive the other product at the second visit
This study will entail 2 in person clinic visits to administer oral doses of SPG601 or matching placebo Participants will receive a dose of either SPG601 or placebo at first visit and will cross over to receive the other product at the second visit
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