Methylphenidate in KBG Syndrome: N-of-1 Series

NCT ID
NCT06465641
Registry status
Recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
Radboud University Medical Center
Conditions
ADHD - Combined Type, Kbg Syndrome

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Effectiveness of Methylphenidate in Children and Adolescents With KBG Syndrome: An N-of-1 Series

Enrollment: 15 participants (Estimated).

What is being studied

  • Intervention: Acids, Carbocyclic
  • Intervention: Carboxylic Acids
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 1-Ring
  • Intervention: Methylphenidate
  • Drug: Methylphenidate Hydrochloride
  • Intervention: Organic Chemicals
  • Intervention: Phenylacetates
  • Intervention: Piperidines
  • Drug: Placebo

Who may be eligible

Ages
6 Years to 20 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Netherlands

  • Gelderland, Netherlands: 1

Sample of listed locations

  • Radboud University Medical Center — Nijmegen, Gelderland, 6500 HB, Netherlands — Recruiting

Study details

Start date
November 13, 2024
Primary completion date
January 1, 2028
Completion date
October 1, 2028
First posted
June 20, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06465641
Registry last updated
August 11, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06465641 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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