NCT05558371 International CDKL5 Clinical Research Network
| NCT ID | NCT05558371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | CDKL5 |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-02-15 |
| Primary Completion | 2026-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-02-15 with a primary completion date of 2026-02-15.
⚠ 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
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.
Eligibility Criteria
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.
Contact & Investigator
Timothy A Benke, MD PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05558371 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 100 Years, studying CDKL5. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05558371 currently recruiting?
Yes, NCT05558371 is actively recruiting participants. Contact the research team at sharon.pincus@cuanschutz.edu for enrollment information.
Where is the NCT05558371 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, Boston, United States, St Louis, United States and 5 additional locations.
Who is sponsoring the NCT05558371 clinical trial?
NCT05558371 is sponsored by University of Colorado, Denver. The principal investigator is Timothy A Benke, MD PhD at University of Colorado, Denver. The trial plans to enroll 1,000 participants.