CDKL5 Deficiency DisorderNCT06663163
The Association Between Fever and CDKL5 Deficiency Disorder: a Nationwide Survey
An observational study of CDKL5 Deficiency Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The primary objective of this research is to study the effects of fever on seizure activity in patients with CDKL5 deficiency disorder Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CDKL5 Deficiency Disorder
- What is being tested?
- Observation
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
The primary objective of this research is to study the effects of fever on seizure activity in patients with CDKL5 deficiency disorder
Read the detailed description
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.
- Conditions
- CDKL5 Deficiency Disorder
- Being tested
- Observation
- Keywords
- CDKL5, Drug Resistant Epilepsy, Survey Research
- Medical subject headings
- CDKL5 deficiency disorder, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
This study was an observational study without intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
The results of seizure reduction reported in the questionnaire completed by the parents or the seizure diary provided online
Measured: Fever episodes within one year leading up to 2 hours of questionnaire completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start29 Oct 2024
- Primary completion15 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CDKL5 Deficiency DisorderStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663163
- Sponsor's protocol ID
- 2024-127-002
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang S, Du J, Liu J, Hu D, Wang H, Man X, Gao L, Hu S, Meng X, Zhao H, Hu M, Yang Y, Xiong Z, Ren L. Nationwide Survey of Association Between Fever and Epileptic Seizure in CDKL5 Deficiency Disorder Revealed Therapeutic Implications. Ann Clin Transl Neurol. 2026 Aug 26. doi: 10.1002/acn3.70517. Online ahead of print.
PubMed 42644218
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Fever and CDKL5 Deficiency Disorder: a Nationwide Survey
- ClinicalTrials.gov ID
- NCT06663163
- Acronym / sponsor ID
- 2024-127-002
- Conditions
- CDKL5 Deficiency Disorder
- Keywords
- CDKL5, Drug Resistant Epilepsy, Survey Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this research is to study the effects of fever on seizure activity in patients with CDKL5 deficiency disorder
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThis study was an observational study without intervention | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 42644218Wang S, Du J, Liu J, Hu D, Wang H, Man X, Gao L, Hu S, Meng X, Zhao H, Hu M, Yang Y, Xiong Z, Ren L. Nationwide Survey of Association Between Fever and Epileptic Seizure in CDKL5 Deficiency Disorder Revealed Therapeutic Implications. Ann Clin Transl Neurol. 2026 Aug 26. doi: 10.1002/acn3.70517. Online ahead of print.
- Individual participant dataSharing planned: No
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Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A PROBE Clinical Trial
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A Retrospective Survey-based Multicenter Study to Delineate the Molecular and Phenotypic Spectrum of Epilepsy-dyskinesia Syndromes
Epilepsy in Children, Dyskinesias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liankun Ren, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CDKL5 Deficiency Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: Fever episodes within one year leading up to 2 hours of questionnaire completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.