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NCT05558371 · ClinicalTrials.gov registry record
International CDKL5 Clinical Research Network
A clinical trial of CDKL5 Deficiency Disorder and CDKL5, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 9
- Study locations
NCT05558371: Recruiting study of CDKL5 Deficiency Disorder and CDKL5, sponsored by University of Colorado, Denver.
NCT05558371 is a study of CDKL5 Deficiency Disorder and CDKL5 that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 1,000 participants. The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05558371, a study of CDKL5 Deficiency Disorder and CDKL5, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Measured by clinician rating of patient. Item scores are transformed to a scale of 0-100 and the total score is calculated as a mean item score. Higher scores indicate higher severity.
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 |
What NCT05558371 shows while recruiting
NCT05558371 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
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.
NCT05558371 lists 9 locations in 9 states (California, Colorado, Massachusetts).
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.
What interventions are being tested in trial NCT05558371?
The interventions under investigation include: No intervention. (OTHER).
Who is sponsoring clinical trial NCT05558371?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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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