Phase
Condition
Down's Syndrome
Treatment
Bumetanide
Placebo
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Principal inclusion criteria
The presence of a free trisomy 21 documented by karyotyping
Adolescents from 10 to 17 years old (included)
3 4.5 ≥ Mental age ≤ 8.5 (as assessed by Leiter-3 at visit 1 or by assessment with Leiter-3 within 6 months of the first visit (Visit 1)
Informed consent from their parents and assent from child/adolescent
Principal exclusion criteria
The presence of any neurosensory deficits, such as hypoacusis or serious visual impairments;
The presence of epilepsy;
The presence of electrolyte disorders;
The presence of clinically and/or hemodynamically significant congenital heart defects, defined as patients with congenital heart disease who already underwent or are awaiting surgical/percutaneous correction (including palliative cardiac surgery as Glenn and/or Fontan) or who are under current treatment with cardiac medications.
The presence of a hypersensibility known about sulpha drugs;
The presence of contraindications relative to the treatment by Bumetanide;
Patients already treated by diuretics;
Any of the following abnormal laboratory values at screening:
Hemoglobin <10 g/dL
Abnormal liver function defined as any 2 or more of the following: ≥3 × upper limit of normal (ULN) aspartate aminotransferase (AST), ≥3 × ULN alanine aminotransferase (ALT), ≥3 × ULN gamma-glutamyl transpeptidase (GGT), ≥3 × ULN alkaline phosphatase (ALP), or ≥2 × ULN total bilirubin
Abnormal liver function defined as any increase of ≥5 × ULN AST or ALT
Estimated glomerular filtration rate ≤80 mL/min/1.73 m2 (calculated by the Schwartz equation)
Plasma HCO3 > 32 i) A 12-lead ECG demonstrating QTc >450 msec at screening; j) Subject's weight less than 25 Kg.
k) Pregnancy as assessed by urine beta HCG
Study Design
Study Description
Connect with a study center
Bambino Gesù Children's Hospital
Rome, 00165
ItalyActive - Recruiting
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