Status:
RECRUITING
Clemastine Treatment in Individuals With Williams Syndrome
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Tel Aviv University
Conditions:
Williams Syndrome
Eligibility:
All Genders
6-30 years
Phase:
PHASE3
Brief 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...
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...
Eligibility Criteria
Inclusion
- Individuals with Williams syndrome, which has been confirmed by genetic testing.
- Ages 6-30.
- Normal values in safety variables (e.g. Normal ECG 120-129/80-84).
- No change in psychotropic medications and dosage during the last 4 weeks.
- During the study, no pharmacological change that may impact the study (e.g. ADHD
- medications).
Exclusion
- Individuals with another genetic disorder besides Williams syndrome.
- Individuals with Williams syndrome, younger than 6 or older than 30 years old.
- Significant change in normal values in safety variables (e.g. high or low ECG).
- Change in medications and dosage during the last 4 weeks prior the beginning and
- during the study.
- Pregnancy.
- Using addictive substances such as alcohol.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06087757
Start Date
April 1 2024
End Date
December 1 2025
Last Update
May 7 2024
Active Locations (2)
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1
Child and Adolescent Psychiatry Unit, Sheba Medical Center
Ramat Gan, Israel
2
Tel Aviv University
Tel Aviv, Israel