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Tests treatment safety and results for Down Syndrome
Official title Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome
ClinicalTrials.gov ID: NCT06465823
What this study is testing
What is Bumetanide?
Bumetanide is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for down syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of the study is to evaluate the clinical efficacy of a known diuretic drug, Bumetanide, in terms of improvement of memory and psychological functioning in children and adolescents with Down syndrome (DS), in order to develop therapeutic strategies for cognitive and psychopathology aspects associated with the syndrome. The study also aims to identify possible predictors and biological and genetic markers related to the efficacy of the treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- Principal 1. 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
You likely can't join if
- 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...
- The presence of a hypersensibility known about sulpha drugs;
- The presence of contraindications relative to the treatment by Bumetanide;
See the full eligibility criteria
- Principal 1. 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.