Clemastine treatment for individuals with Williams syndrome
Clemastine Treatment in Individuals With Williams Syndrome- a Double-blind Placebo Control to Assess the Safety and Efficacy
This study is testing if the medication Clemastine can help improve thinking, movement, and behavior in young people with Williams syndrome.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 30 Years |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 2 sites (Ramat-Gan and 1 other locations) |
| Trial ID | NCT06087757 on ClinicalTrials.gov |
What this trial studies
This study investigates the neurobiological aspects of Williams syndrome and evaluates the potential of Clemastine as a treatment for cognitive, motor, and behavioral deficits associated with the condition. Participants aged 6 to 30 with confirmed Williams syndrome will receive Clemastine in an age-dependent dosage, followed by a randomized, double-blind, placebo-controlled phase after initial treatment. The study aims to assess the safety and effectiveness of Clemastine in improving neurocognitive outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 6 to 30 with a confirmed diagnosis of Williams syndrome.
Not a fit: Patients with other genetic disorders or those outside the age range of 6 to 30 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive and behavioral functioning in individuals with Williams syndrome.
How similar studies have performed: While there is limited research specifically on Clemastine for Williams syndrome, similar approaches targeting cognitive deficits in genetic disorders have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ramat-Gan and 1 other locations
- Child and Adolescent Psychiatry Unit, Sheba Medical Center — Ramat-Gan, Israel (Recruiting)
- Tel Aviv University — Tel Aviv, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.