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International CDKL5 Clinical Research Network
NCT05558371 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER No intervention.
Study Locations (9)
California
- University of California Los Angeles/UCLA Mattel Children's Hospital — Los Angeles
Colorado
- University of Colorado Denver/Children's Hospital Colorado — Aurora
Massachusetts
- Harvard Medical School/Boston Children's Hospital — Boston
Missouri
- Washington University in St. Louis/St. Louis Children's Hospital — St Louis
New York
- NYU Langone Health — New York
Ohio
- Cleveland Clinic Foundation — Cleveland
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Texas
- Baylor College of Medicine/ Texas Children's Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2027-02-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05558371
The ClinicalTrials.gov registry entry for NCT05558371 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with CDKL5 Deficiency Disorder appearing as the primary indexed condition, and to 1 intervention — of which No intervention. is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05558371 reports 9 study locations spanning 9 distinct geographic areas — top geographies include California, Colorado, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05558371 about?
NCT05558371 is a clinical study titled "International CDKL5 Clinical Research Network". 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...
What is the current status of trial NCT05558371?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2021-02-15. Estimated completion is 2027-02-15.
What conditions does trial NCT05558371 study?
This clinical trial studies the following conditions: CDKL5 Deficiency Disorder, CDKL5, CDD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05558371?
The interventions under investigation include: No intervention. (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05558371?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05558371 being conducted?
This trial has 9 study locations across California, Colorado, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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