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Completed

NCT Number: NCT06663163

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

The survey aimed to gather information on seizure during and after fever and hot temperature bath therapy from families of children diagnosed with CDKL5 deficiency disorder through the WeChat group. It is expected to to develop new intervention strategies to reduce seizure frequency, improve patient quality of life, and ultimately address the therapeutic challenges faced by the global CDKL5 patient community.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

observation

Other

This study was an observational study without intervention

Primary outcomes

  1. Seizure frequency

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

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

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 29, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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