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Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome

NCT06315699 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-19

No results posted yet for this study

Summary

This study focuses on therapeutic targets for cognitive, motor, and social impairments in Williams syndrome by reversing brain myelin defects caused by GTF2I. The primary objective of the study was to test and evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome.

Conditions

  • Williams Syndrome
  • Child
  • Neurodevelopmental Delay

Interventions

DRUG

Clemastine Fumarate Tablets

clemastine fumarate (0.178 mg/kg/day), three months

DIETARY_SUPPLEMENT

corn starch tablets

The dose was administered 2mg once daily in a double-blind random crossover method

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • cao aihua, post-doctoral · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2025-03-02
Completion
2025-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315699 on ClinicalTrials.gov