CTIS2023-506202-40-01
Active, not recruiting
Phase 1
Effectiveness of methylphenidate in children and adolescents with KBG syndrome: An N-of-1 series - 113883
Stichting Radboud University Medical Center0 sites15 target enrollmentMarch 26, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stichting Radboud University Medical Center
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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, Inability to understand or speak Dutch, 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 methylphenidate, 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
Outcomes
Primary Outcomes
Not specified
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