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Study identifier: NCT05558371 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

International CDKL5 Clinical Research Network

Condition: CDKL5 · CDKL5 Deficiency Disorder · CDD  ·  Sponsor: University of Colorado, Denver

PhaseN/A
Planned participants1000
Who can joinAll sexes, 1 Month to 100 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sharon R Pincus, MA  ·  303-949-7116  ·  sharon.pincus@cuanschutz.edu

Scott T Demarest, MD MSCS  ·  iccrn@childrenscolorado.org

Always discuss trial participation with your own doctor first.

Locations (9)

University of California Los Angeles/UCLA Mattel Children's HospitalLos Angeles, California, United StatesRecruiting
University of Colorado Denver/Children's Hospital ColoradoAurora, Colorado, United StatesRecruiting
Harvard Medical School/Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Washington University in St. Louis/St. Louis Children's HospitalSt Louis, Missouri, United StatesRecruiting
NYU Langone HealthNew York, New York, United StatesRecruiting
Cleveland Clinic FoundationCleveland, Ohio, United StatesRecruiting
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United StatesRecruiting
Baylor College of Medicine/ Texas Children's HospitalHouston, Texas, United StatesRecruiting
Telethon Kids Institute/Perth Children's HospitalPerth, Nedlands Western Australia, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT05558371