NCT06087757

Clemastine Treatment in Individuals With Williams Syndrome

Clemastine Treatment in Individuals With Williams Syndrome- a Double-blind Placebo Control to Assess the Safety and Efficacy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 6 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This study explores the neurobiological etiology of Williams syndrome and potential therapeutic targets for associated social, motor, and cognitive abnormalities. The main translational objective will be to test the effectiveness of Clemasntine on neurocognitive and other associated abnormalities in individuals with Williams syndrome.

Detailed description

The overarching aim of the research proposed is to examine the safty of Clemastine use for individuals with Williams syndrome. Further, we wish to examine the relationship between Clemastine treatment and cognitive, motor and behavioral deficits in individuals with Williams syndrome. This study is an open-label study with a blinded randomize withdrawal. Each participant will go through a baseline evaluation (see study outcomes) and will be treated with the FDA approved drug Clemastine, in an age dependent dose (dosage table below). After a substantial improvement will be noticed, the participants will be divided into 2 groups, in a randomized, double-blind, placebo-control study design.

Conditions

• Williams Syndrome

Interventions

Type	Name	Description
DRUG	Open Label Clemastine with a blinded randomize withdrawal	Clemastine will be given in doses as the maximum dose recommended for allergy condition. Age 6-12 years 4.02 mg/day, age 12-30 years 8.04 mg/day.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2023-10-18
• Last updated: 2026-03-06

Locations

2 sites across 1 country: Israel