Last updated: March 11, 2024
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting
Phase
3
Condition
Williams Syndrome
Treatment
Clemastine Fumarate Tablets
fructose
Clinical Study ID
NCT06315699
QL000001
MR-37-24-002019
Ages 3-6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 3-6 years old;
- Positive fluorescence in situ hybridization (FISH) test confirmed Williams syndrome;
- GTF2I gene mutation was detected by whole exon;
- Heart safety variables are normal (e.g. normal ECG, blood pressure 120-129/80-84)
Exclusion
Exclusion Criteria:
- WS patients with other gene mutations;
- Used antihistamines, monoamine oxidase inhibitors, barbiturates and sedatives, as wellas drugs affecting cognitive behavior, limb movement, white matter myelin, and MRIwithin 2 months before enrollment;
- Patients with narrow-angle glaucoma, narrow peptic ulcer, pyloroduodenal obstruction,symptomatic prostatic hypertrophy and bladder neck obstruction; Accompanied by severeimmunodeficiency disease;
- Allergic to Clomastine fumarate or other arylalkylamine antihistamines or anyreceptor;
- According to the recent interpretation of MRI and neuroradiology experts or WS, thereare obvious brain lesions that are not related to WS disease;
- Clinically significant metabolic, hematological, liver, immune, urinary, endocrine,neurological, pulmonary, psychiatric, skin, allergic, renal, or other major diseasesthat may affect the interpretation of study findings or patient safety in WS'sjudgment;
Study Design
Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Clemastine Fumarate Tablets
Phase: 3
Study Start date:
March 20, 2024
Estimated Completion Date:
December 30, 2025
Study Description
Connect with a study center
Qilu Hospital of Shandong University
Tainan, Shangdong 250012
ChinaActive - Recruiting
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