NCT06087757

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
1mo left

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Apr 2024Jul 2026

First Submitted

Initial submission to the registry

October 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

October 5, 2023

Last Update Submit

March 4, 2026

Conditions

Williams Syndrome

Keywords

ClemastineCognitionMyelination abnormalities

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive measures

    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/

    December 2024

Secondary Outcomes (1)

  • Motor and Neurological assessment. Motor and Neurological assessment. Motor and Neurological assessment. Motor and neurolocgial measures

    December 2024

Study Arms (2)

Open Label

EXPERIMENTAL
Drug: Open Label Clemastine with a blinded randomize withdrawal

Blinded randomize withdrawal

EXPERIMENTAL
Drug: Open Label Clemastine with a blinded randomize withdrawal

Interventions

Open Label Clemastine with a blinded randomize withdrawalDRUG

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.

Blinded randomize withdrawalOpen Label

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Child and Adolescent Psychiatry Unit, Sheba Medical Center

Ramat Gan, Israel

Location

Tel Aviv University

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Williams Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAortic Stenosis, SupravalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This study is an open-label study with a blinded randomized withdrawal
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of The Child and Adolescent Psychiatry Unit

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 18, 2023

Study Start

April 1, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

IL(2)