Williams syndrome
Conditions
Interventions
Experimental Group:Administer climastine fumarate oral preparation intervention
Control group:Administer a placebo preparation with the same appearance and dosing frequency as the administration regimen of the test group.
Sponsors
Children’s Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 2–6 years; 2. Patients definitely diagnosed with Williams syndrome (7q11.23 deletion) via genetic testing, including FISH, MLPA, CMA, WES or WGS; 3. The guardian has signed the informed consent form, and the participant is willing to cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Concomitant other hereditary diseases, chromosomal abnormalities, or atypical Williams syndrome (WS) genetic defects; 2. Prolonged QT/QTc interval on electrocardiography; 3. Use of the following medications within the past 8 weeks: central nervous system depressants (benzodiazepines, barbiturates), psychoactive drugs affecting cognition and behavior, drugs influencing myelination or MRI manifestations, monoamine oxidase inhibitors (MAOIs), antihistamines, and other related agents; 4. Allergy to clemastine or other arylalkylamine antihistamines; 5. Presence of any of the following comorbid medical conditions: asthma, hyperthyroidism, angle-closure glaucoma, gastrointestinal obstruction, significant prostatic or bladder outlet obstruction, severe immunodeficiency, etc.; 6. Significant intracranial lesions identified on MRI (e.g., intracranial tumors, severe cerebral malformations, post-traumatic brain changes); 7. Severe systemic comorbidities that may interfere with study assessments, including metabolic, hepatic, renal, cardiac, pulmonary, endocrine, immune, neuropsychiatric and other disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Cognitive/Developmental Quotient;Changes in DTI indicators of white matter structure;Changes in emotional and anxiety-related behavioral symptoms;Changes in other MRI imaging indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fine and gross motor function;Changes in social skills and adaptive behavior; | — |
Countries
China
Contacts
Public ContactJi Chai
Children’s Hospital, Zhejiang University School of Medicine
Outcome results
None listed