Methylphenidate in KBG Syndrome: N-of-1 Series
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Kbg Syndrome, ADHD - Combined Type
In brief
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.
Key facts
- Study ID
- NCT06465641
- Run by
- Radboud University Medical Center
- People needed
- 15
- Starts
- 2024-11-13
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2024-12-27
Who can join
Age: 6 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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