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International CDKL5 Clinical Research Network

Recruitingn/aAges 1 Month - 100 YearsAllUniversity of Colorado, Denver
NCT05558371 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pathogenic variants in the Cyclin-dependent kinase like 5 (CDKL5) gene cause CDKL5 deficiency disorder (CDD, MIM 300672, 105830), a severe developmental and epileptic encephalopathy associated with cognitive and motor impairments and cortical visual impairment. While capability for disease modifying therapies is accelerating, there is a critical barrier for clinical trial readiness that may result in failure of these therapies, not due to lack of efficacy but due to lack of validated outcome measures and biomarkers. The measures and biomarkers validated here will be adaptable to other developmental and epileptic encephalopathies.

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📋 Eligibility rules (as published)
Inclusion Criteria: * All children diagnosed with CDD age 1-month to 100 years of age that are receiving care at one of the study institutions or are registered with the International CDKL5 Disorder Database will be considered for the study population. Exclusion Criteria: * Individuals who do not meet study inclusion criteria.
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What it tests

  • No intervention.
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Where

9 sites
University of California Los Angeles/UCLA Mattel Children's Hospital
Los Angeles, United States
University of Colorado Denver/Children's Hospital Colorado
Aurora, United States
Harvard Medical School/Boston Children's Hospital
Boston, United States
Washington University in St. Louis/St. Louis Children's Hospital
St Louis, United States
NYU Langone Health
New York, United States
Cleveland Clinic Foundation
Cleveland, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Baylor College of Medicine/ Texas Children's Hospital
Houston, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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