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Clemastine Treatment in Individuals With Williams Syndrome

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ClinicalTrials.gov Identifier: NCT06087757
Recruitment Status : Recruiting
First Posted : October 18, 2023
Last Update Posted : May 7, 2024
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Prof. Doron Gothelf MD, Sheba Medical Center

Study Description
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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 be to test the effectiveness of Clemasntine on neurocognitive and other associated abnormalities in individuals with Williams syndrome.

Condition or disease Intervention/treatment Phase
Williams Syndrome Drug: Open Label Clemastine with a blinded randomize withdrawal Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: This study is an open-label study with a blinded randomized withdrawal
Primary Purpose: Treatment
Official Title: Clemastine Treatment in Individuals With Williams Syndrome- a Double-blind Placebo Control to Assess the Safety and Efficacy
Actual Study Start Date : April 1, 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label 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.
Experimental: Blinded randomize withdrawal 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.


Outcome Measures
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Primary Outcome Measures :
  1. Neurocognitive measures [ Time Frame: December 2024 ]

    Wechsler Intelligence Scale: The standard age-appropriate Wechsler scale. Wechsler Intelligence Scale for Children, 4th edition(Wechsler 1991, Wechsler 2003) for subjects 17 years and younger and the Wechsler Adult Intelligence Scale, 3rd edition (WAIS III)(Wechsler 1997) for subjects older than 17 years.

    NIH ToolBox (NIHTB): the NIHTB is a computerized neurocognitive battery developed by NIH that was designed to include measures of cognitive flexibility and inhibitory control, as well as a measure of working memory. http://www.healthmeasures.net/explore-measurement-systems/nih-toolbox/



Secondary Outcome Measures :
  1. Motor and Neurological assessment. Motor and Neurological assessment. Motor and Neurological assessment. Motor and neurolocgial measures [ Time Frame: December 2024 ]

    The Beery-Buktenica Developmental Test of Visual-Motor Integration

    GAITRite walkway: GAITRite is a sensitive walkway measuring temporal and spatial parameters.

    Psychiatric evaluation: a semi-structured interview for neuropsychiatric diagnoses with the Schedule for Affective Disorders and Schizophrenia for School-Aged Children.

    The Child Behavior Checklist: measures behavioral/emotional problems and competencies.

    Attention Deficit Hyperactivity Disorder Rating Scale.

    The Screen for Child Anxiety-Related Emotional Disorders.

    The Social Responsiveness Scale-Second Edition.

    Adaptive Behavior Assessment System-2nd Edition.



Eligibility Criteria
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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06087757


Locations
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Israel
Child and Adolescent Psychiatry Unit, Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Prof. Doron Gothelf, MD    972-52-6669360    gothelf@post.tau.ac.il   
Tel Aviv University Recruiting
Tel Aviv, Israel
Contact: Doron Gothelf    972-54-666-9360    gothelf@tauex.tau.ac.il   
Sponsors and Collaborators
Sheba Medical Center
Tel Aviv University
More Information
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Responsible Party: Prof. Doron Gothelf MD, Head of The Child and Adolescent Psychiatry Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT06087757    
Other Study ID Numbers: 9011-21-SMC
First Posted: October 18, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof. Doron Gothelf MD, Sheba Medical Center:
Clemastine
Cognition
Myelination abnormalities
Additional relevant MeSH terms:
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Williams Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Aortic Stenosis, Supravalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
 Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Clemastine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents