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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Contact Information
Primary
Charlotte Ockeloen, MD
charlotte.ockeloen@radboudumc.nl
+31243613946
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 15
Treatments
Active_comparator: Methylphenidate
Methylphenidate hydrochloride in capsules
Placebo_comparator: Placebo
Microcrystalline cellulose in capsules
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov

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