Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315699
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-04
Brief Title:
Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
Randomized Double-blind Controlled Study of Clomastine Fumarate in the Treatment of Williams Syndrome
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 study focuses on therapeutic targets for cognitive motor and social impairments in Williams syndrome by reversing brain myelin defects caused by GTF2I The primary objective of the study was to test and evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome
Detailed Description:
The primary objective of this study was to evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome The secondary objective is to study Clomastine fumarate in relation to mechanisms of action safety andor pathological mechanisms This study was an open-label study with a randomized cross-over placebo-controlled design Each participant will be randomly assigned to two groups through baseline assessment see study results with Group A receiving the FDA-approved drug Clemastine at a weight-dependent dose see dosing table below for the first cycle and placebo for the second cycle Group B will be treated with placebo for the first cycle and the FDA-approved drug Clemastine for the second cycle
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MR-37-24-002019 | REGISTRY | Chinese Clinical Trial Registry | None |