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NCT05373719 · ClinicalTrials.gov registry record

Observational Study in Patients With Cyclin-dependent Kinase-like 5 Deficiency Disorder

A clinical trial of Cyclin-Dependent Kinase-Like 5 Deficiency Disorder, sponsored by Loulou Foundation.

Active
Registry status
112
Enrollment target
20
Study locations

NCT05373719: Active study of Cyclin-Dependent Kinase-Like 5 Deficiency Disorder, sponsored by Loulou Foundation.

NCT05373719 is a study of Cyclin-Dependent Kinase-Like 5 Deficiency Disorder that is active but no longer recruiting, run by Loulou Foundation. The registered enrollment target is 112 participants. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05373719, a study of Cyclin-Dependent Kinase-Like 5 Deficiency Disorder, is active but no longer recruiting, sponsored by Loulou Foundation.

ACTIVE NOT RECRUITING
Registry status
112 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

Suitability of this cognition and global development scale in CDD will be assessed based on the number of tests completed, ceiling/floor effect and variance estimate.

Interventions

  • OTHER No intervention; observational

Study Locations (20)

Other

  • Alberta Children's Hospital, Pediatric Epilepsy and Child Neurology - Calgary
  • The Hospital of Sick Children - Toronto
  • Hopital Necker- Enfants Malades - Paris
  • DRK Berlin - Epilepsiezentrum und Neuropädiatrie - Berlin
  • Schön Klinik Vogtareuth - Vogtareuth
  • Azienda Ospedaliero-Universitaria Meyer - Florence
  • Fondazione Policlinico Universitario A Gemelli, IRCCS - Roma
  • Ospedale Pediatrico Bambino Gesù - Rome
  • Azienda Ospedaliera Universitaria Integrata di Verona - Verona
  • Hospital Infantil Universitario Niño Jesús - Madrid
  • Ruber Internacional Hospital - Madrid

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • The Cleveland Clinic - Cleveland

California

  • UCLA Mattel Children's Hospital - Los Angeles

Colorado

  • Children's Hospital Colorado - Aurora

Georgia

  • Center for Rare Neurological Diseases - Norcross

Massachusetts

  • Boston Children's Hospital - Boston

New York

  • New York University - New York

Pennsylvania

  • Childrens Hospital of Philadlephia Division of Neurology - Philadelphia

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2022-09-30
Est. Completion 2027-01-20
Loulou Foundation

1 total trials

What the registry record for NCT05373719 still lists

NCT05373719 is an observational study that tracks outcomes without assigning an intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Cyclin-Dependent Kinase-Like 5 Deficiency Disorder appearing as the primary indexed condition, and to 1 intervention - of which No intervention; observational is the first listed.

NCT05373719 names 20 study sites across 9 states, led by Other, Ohio, California.

Frequently Asked Questions

What is clinical trial NCT05373719 about?

NCT05373719 is a clinical study titled "Observational Study in Patients With Cyclin-dependent Kinase-like 5 Deficiency Disorder". 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.

What is the current status of trial NCT05373719?

This trial is currently active not recruiting. The enrollment target is 112 participants. The study started on 2022-09-30. Estimated completion is 2027-01-20.

What conditions does trial NCT05373719 study?

This clinical trial studies the following conditions: Cyclin-Dependent Kinase-Like 5 Deficiency Disorder.

What interventions are being tested in trial NCT05373719?

The interventions under investigation include: No intervention; observational (OTHER).

Who is sponsoring clinical trial NCT05373719?

This trial is sponsored by Loulou Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05373719 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05373719, the US trial registry maintained by the National Library of Medicine. NCT05373719 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.