The Association Between Fever and CDKL5 Deficiency Disorder: a Nationwide Survey

NCT06663163 | Completed

• 1 other identifier: 2024-127-002
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this research is to study the effects of fever on seizure activity in patients with CDKL5 deficiency disorder

Conditions

CDKL5 Deficiency Disorder

Keywords

CDKL5; Drug Resistant Epilepsy; Survey Research

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

  The results of seizure reduction reported in the questionnaire completed by the parents or the seizure diary provided online

  Fever episodes within one year leading up to 2 hours of questionnaire completion

Interventions

Observation OTHER

This study was an observational study without intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female children with a diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures.

You may qualify if:

• A diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures.
• Parents or guardians are willing to complete and provide information about the child's medical history and fever history after receiving the survey questionnaire online.

You may not qualify if:

• Any history of previous brain disease (trauma, etc.) that likely to precipitate seizures.
• Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

CDKL5 deficiency disorder; Drug Resistant Epilepsy

Interventions

Observation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Liankun Ren, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: October 29, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 31, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)