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Clinical Trial 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.


Clinical Trial 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, and/or 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 Design


Related Conditions & MeSH terms


NCT number NCT06315699
Study type Interventional
Source Qilu Hospital of Shandong University
Contact cao aihua, post-doctoral
Phone 18560086317
Email xinercah@163.com
Status Recruiting
Phase Phase 3
Start date March 20, 2024
Completion date December 30, 2025

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