Actively Recruiting

Age: 1Month - 100Years
All Genders
NCT05558371

International CDKL5 Clinical Research Network

Led by University of Colorado, Denver · Updated on 2023-12-06

1000

Participants Needed

9

Research Sites

313 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

International CDKL5 Clinical Research Network

Who Can Participate

Age: 1Month - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children diagnosed with CDKL5 Deficiency Disorder (CDD) aged 1 month to 100 years
  • Receiving care at a participating study institution or registered with the International CDKL5 Disorder Database
Not Eligible

You will not qualify if you...

  • Individuals who do not meet the inclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

University of California Los Angeles/UCLA Mattel Children's Hospital

Los Angeles, California, United States, 90095

Actively Recruiting

2

University of Colorado Denver/Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

3

Harvard Medical School/Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

4

Washington University in St. Louis/St. Louis Children's Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

5

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

6

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

7

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

8

Baylor College of Medicine/ Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

9

Telethon Kids Institute/Perth Children's Hospital

Perth, Nedlands Western Australia, Australia, 6009

Actively Recruiting

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Research Team

S

Sharon R Pincus, MA

CONTACT

S

Scott T Demarest, MD MSCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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