NCT06465641 Methylphenidate in KBG Syndrome: N-of-1 Series
| NCT ID | NCT06465641 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Radboud University Medical Center |
| Condition | Kbg Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 15 participants in total. It began in 2024-11-13 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06465641 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 20 Years, studying Kbg Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06465641 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06465641 currently recruiting?
Yes, NCT06465641 is actively recruiting participants. Contact the research team at charlotte.ockeloen@radboudumc.nl for enrollment information.
Where is the NCT06465641 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT06465641 clinical trial?
NCT06465641 is sponsored by Radboud University Medical Center. The trial plans to enroll 15 participants.