NCT05373719Active, not recruiting
Observational Study in Patients With Cyclin-dependent Kinase-like 5 Deficiency Disorder
Endpoint Enabling Study of Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD)
Source: ClinicalTrials.gov · Last updated 10 Mar 2025
Brief summary (registry, in English)
Observational, noninterventional, 3-year study to examine the presence of detectable differences in neurocognitive, developmental, motor, neurophysiologic, and quality of life measures over time in patients with cyclin-dependent kinase-like 5 deficiency disorder.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 112 (actual)
- First submitted
- 6 May 2022
- Start date
- 30 Sept 2022
- Primary completion date
- 20 Jan 2027
- Lead sponsor
- Loulou Foundation
- NCT number
- NCT05373719
What you commit to
- Study type: Observational
- Participants enrolled: 112
- From 30 Sept 2022 to the primary completion date, 20 Jan 2027
- 22 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any clinically significant neurocognitive deficit not attributable to Cyclin-dependent Kinase-like 5 (CDKL5) deficiency disorder or a secondary cause that may, in the opinion of the investigator, confound interpretation of study results (e.g., extreme prematurity, other genetic variants, unclassified CDKL5 variant, abnormal brain imaging, imaging and/or injury not otherwise attributable to CDD).
- Any condition that, in the opinion of the investigator, would put the patient at undue risk or make it unsafe for the patient to participate
- Any condition which would make the individual or the caregiver, in the opinion of the investigator, unsuitable for the study
Who the study is looking for
- Documented diagnosis of Cyclin-dependent Kinase-like 5 (CDKL5) deficiency disorder with pathogenic or likely pathogenic of CDKL5 variants
- Ages newborn to 55 years old
- Parent/Caregiver who is willing and capable of providing written informed consent
- Parent/caregiver lives with or has daily contact with study participant and able to provide consistent information across the study
Age in the registry: - to 55 years · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mediclinic Coordinator of this site? Confirm its status | Dubai | United Arab Emirates | Unknown status |
| Alberta Children's Hospital, Pediatric Epilepsy and Child Neurology Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| The Hospital of Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| DRK Berlin - Epilepsiezentrum und Neuropädiatrie Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Schön Klinik Vogtareuth Coordinator of this site? Confirm its status | Vogtareuth | Germany | Unknown status |
| Ruber Internacional Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital UniversitarioVithas Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Azienda Ospedaliero-Universitaria Meyer Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Integrata di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UCLA Mattel Children's Hospital Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| New York University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Center for Rare Neurological Diseases Coordinator of this site? Confirm its status | Norcross | United States | Unknown status |
| Childrens Hospital of Philadlephia Division of Neurology Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.