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International CDKL5 Clinical Research Network

NCT05558371 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-12-06

No results posted yet for this 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

  • CDKL5
  • CDKL5 Deficiency Disorder
  • CDD

Interventions

OTHER

No intervention.

No intervention administered as part of this study; observational only.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • International Foundation for CDKL5 Research

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Timothy A Benke, MD PhD · University of Colorado, Denver

Eligibility

Min Age
1 Month
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2026-02-15
Completion
2027-02-15

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558371 on ClinicalTrials.gov