🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Cornelia De Lange Syndrome: Assessing Positive Effects of Lithium Treatment

RecruitingPhase 2, Phase 3Ages 4 Years - anyAllUniversity of Milan
NCT06789783 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

The study "Cornelia de Lange Syndrome: assessing positive effects of Lithium treatment - CLoSER" aims to evaluate the effectiveness on behavioral modifications of lithium carbonate therapy in patients with Cornelia de Lange syndrome (CdLS). CdLS is a rare genetic disease caused by autosomal mutations dominant or X-linked. The prevalence of CdLS is estimated to be between 1:10,000-30,000 newborns, but it is probably underestimated because the most cases mild ones may go undiagnosed. This syndrome is characterized by slow growth before and after birth with intellectual disability and short stature, from major malformations such as facial anomalies, neurological disorders, gastrointestinal and musculoskeletal malformations. To date, for these patients only targeted medical and surgical therapeutic interventions are recommended for improving the quality of life. No drug therapy is validated

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * Age \> 4 years * Body weight within the normal range in the reference range for CdLS, based on age and height * Diagnosis of CdLS based on consensus clinical criteria and a confirmed mutation in the NIPBL gene * Stable drug regimen for 4 weeks prior to starting the study * Written consent signed by parent/legal guardian/representative prior to the screening visit * Ability to take the study drug provided in capsules or drops (for younger patients and those with swallowing difficulties) or combined with food/drinks * Caregiver must be able to understand the instructions and participate knowingly in the study Exclusion Criteria: * The patient is participating in another clinical trial * QT interval prolongation, thyroid dysfunction, renal insufficiency, hepatic insufficiency, leukopenia, or other currently clinically significant medical disorders (as determined by the investigator), other than those directly related to CdLS * QTcF interval on ECG greater than 450 msec * Severe diabetes mellitus or inherited metabolic disorder
💊

What it tests

  • Lithium Carbonate Capsule
📍

Where

1 site
University of Milan
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy