Actively Recruiting
Methylphenidate in KBG Syndrome: N-of-1 Series
Led by Radboud University Medical Center · Updated on 2024-12-27
15
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Methylphenidate in KBG Syndrome: N-of-1 Series
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6-20 years
- Molecularly confirmed diagnosis of KBG syndrome (pathogenic ANKRD11 variant or chromosome 16q24 deletion including ANKRD11)
- Attention deficit or ADHD-related symptoms or formal ADHD diagnosis with significant impact on daily life
- Presence of a caregiver or supervisor for proxy reports
You will not qualify if you...
- Family history of acute cardiac death requiring further cardiac investigation
- History of cardiovascular disease such as severe hypertension, heart failure, arterial occlusive disease, life-threatening arrhythmias, angina pectoris, significant congenital heart defect, cardiomyopathy, myocardial infarction, or channelopathy
- Current or past hyperthyroidism, glaucoma, or pheochromocytoma
- Use of psychotropic or stimulant drugs interacting with methylphenidate
- History of schizophrenic or psychotic disorder
- Unstable epilepsy not controlled with medication
- History of frequent drug or alcohol abuse
- Excessive alcohol or drug use or intoxication during the study
- Pregnant or lactating women
- Inability to understand or speak Dutch
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Actively Recruiting
Research Team
C
Charlotte Ockeloen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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