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Methylphenidate in KBG Syndrome: N-of-1 Series

RecruitingPhase 4Ages 6 Years - 20 YearsAllRadboud University Medical Center
NCT06465641 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial\] is to learn about the effect of methylphenidate in children and adolescents with KBG syndrome. The main question it aims to answer is: • What is the effectiveness of methylphenidate on attention deficit and ADHD-related symptoms in children and adolescents with KBG syndrome? Participants will receive multiple blocks of treatment with methylphenidate and placebo and fill out various questionnaires.

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 6-20 years * Molecularly confirmed diagnosis of KBG syndrome (pathogenic ANKRD11 variant or a chromosome 16q24 deletion including ANKRD11) * Attention deficit or ADHD-related symptoms or a formal ADHD diagnosis, with a significant impact on daily life\* * Presence of a subject's caregiver or supervisor for proxy-reports Exclusion Criteria: * Family history of acute cardiac death that warrants further cardiac investigation * Cardiovascular disease in medical history (severe hypertension, heart failure, arterial occlusive disease, potentially life-threatening arrythmias, angina pectoris, hemodynamically significant congenital heart defect, cardiomyopathy, myocardial infarction and channelopathy) * Current or previous presence of hyperthyroidism, glaucoma or pheochromocytoma * Use of (psychotropic/stimulant) drugs which interact with MPH * Schizophrenic or psychotic disorder in medical history * Unstable epilepsy (not controlled with medication) * History of frequent drug and/or alcohol abuse * Excessive alcohol/drug use and/or intoxication with one or both during the study * Pregnant or lactating women * Inability to understand or speak Dutch
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What it tests

  • Methylphenidate Hydrochloride
  • Placebo
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Where

1 site
Radboud University Medical Center
Nijmegen, Netherlands
🤝 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.
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