CDKL5 Deficiency DisorderNCT06447675
Efficacy and Safety Evaluation of Hyperthermic Baths in the Treatment of Seizures in CDKL5 Deficiency Disorder
A study testing Hyperthermic Baths in people with 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 efficacy and safety of hyperthermic baths as adjunctive therapy for reducing the frequency of seizures in CDKL5 deficiency. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- CDKL5 Deficiency Disorder
- What is being tested?
- Hyperthermic Baths
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 30 Sep 2025
- Phase
- Interventional
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
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
- Male or female participants aged 6 months to less than 6 years
- Parent(s) or LAR willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures
- Failure to control seizures despite appropriate trial of 2 or more anti-seizure medications at therapeutic doses
- Have a history of at least 8 countable seizures per 4 weeks during the 8 weeks prior to screening. Countable seizures will be defined by the following:Seizures with or without impairment of consciousness with a clear motor component, including generalized tonic-clonic, focal to bilateral tonic-clonic, atonic, bilateral clonic, bilateral tonic, focal motor seizures with or without impaired awareness, or infantile spasms. Clusters of infantile spasms/tonic seizures will be counted as a single seizure.
- Participants should be on a stable regimen of anti-seizure medications for ≥ 4 weeks prior to the screening visit, without a foreseeable change in dosing for the duration of the DB phase.
- Vagus nerve stimulator (VNS) are permitted, but should be implanted for 1 year prior to screening and settings should be unchanged throughout the study.
- Parent/caregiver is able and willing to maintain an accurate and complete daily seizure eDiary for the duration of the study.
Who cannot join
- Any history of previous brain disease (trauma, etc.) that likely to precipitate seizures.
- Tissue damage (eczema, etc.) in the area where hyperthermic baths will be applied on the skin.
- Seizures associated with hyperthermic baths.
- 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
Official title: Efficacy and Safety Evaluation of Hyperthermic Baths in the Treatment of Seizures in CDKL5 Deficiency Disorder: A Single-center, Self Control Trial
The primary objective of this research is to study the efficacy and safety of hyperthermic baths as adjunctive therapy for reducing the frequency of seizures in CDKL5 deficiency.
Read the detailed description
This project aims to include 8 participants, and evaluate the effectiveness and safety of hyperthermic baths in patients with CDKL5 deficiency through A single-center, preliminary feasibility clinical trial. It is expected to provide new therapeutic options for patients with CDKL5 deficiency with alternative treatment options.
- Conditions
- CDKL5 Deficiency Disorder
- Being tested
- Hyperthermic Baths
- Keywords
- Hyperthermic Baths, Drug Resistant Epilepsy, CDKL5
- 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.
Hyperthermic BathsOther
The intervention will consist of 12 weeks of repeated, daily 20-min body immersions.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermic Baths | Experimental | Patients with CDKL5 deficiency assigned to hyperthermic baths will have their body immersed in a hot water (40~42°C) bath for 20 min per session. Receives: Other: Hyperthermic Baths |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency (SF28)
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval:
SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as SF28 in the baseline period. The seizure frequency in the treatment phase is defined as SF28 per month during the treatment period. Percent change in seizure frequency=100*(treatment SF28-baseline SF28)/baseline SF28.
Measured: Up to 12 week after hyperthermic baths
Secondary outcomes (2)
Seizure Responder Rate
The proportion of patients with a ≥ 25%, ≥50% reduction from Baseline in seizure frequency.
Measured: Up to 12 week after hyperthermic baths
Seizure-free Days
Seizure-free days over the entire treatment phase
Measured: Up to 12 week after hyperthermic baths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start20 Sep 2024
- Primary completion25 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT06447675
- Sponsor's protocol ID
- 2024-111-002
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Hyperthermic Baths in the Treatment of Seizures in CDKL5 Deficiency Disorder: A Single-center, Self Control Trial
- ClinicalTrials.gov ID
- NCT06447675
- Acronym / sponsor ID
- 2024-111-002
- Conditions
- CDKL5 Deficiency Disorder
- Keywords
- Hyperthermic Baths, Drug Resistant Epilepsy, CDKL5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Jun 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 efficacy and safety of hyperthermic baths as adjunctive therapy for reducing the frequency of seizures in CDKL5 deficiency.
Detailed description
This project aims to include 8 participants, and evaluate the effectiveness and safety of hyperthermic baths in patients with CDKL5 deficiency through A single-center, preliminary feasibility clinical trial. It is expected to provide new therapeutic options for patients with CDKL5 deficiency with alternative treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermic Baths | Experimental | Other: Hyperthermic BathsPatients with CDKL5 deficiency assigned to hyperthermic baths will have their body immersed in a hot water (40~42°C) bath for 20 min per session. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- A diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures
- Male or female participants aged 6 months to less than 6 years
- Parent(s) or LAR willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures
- Failure to control seizures despite appropriate trial of 2 or more anti-seizure medications at therapeutic doses
- Have a history of at least 8 countable seizures per 4 weeks during the 8 weeks prior to screening. Countable seizures will be defined by the following:Seizures with or without impairment of consciousness with a clear motor component, including generalized tonic-clonic, focal to bilateral tonic-clonic, atonic, bilateral clonic, bilateral tonic, focal motor seizures with or without impaired awareness, or infantile spasms. Clusters of infantile spasms/tonic seizures will be counted as a single seizure.
Key exclusion criteria (4 listed)
- Any history of previous brain disease (trauma, etc.) that likely to precipitate seizures.
- Tissue damage (eczema, etc.) in the area where hyperthermic baths will be applied on the skin.
- Seizures associated with hyperthermic baths.
- 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 |
|---|---|---|
| Hyperthermic BathsThe intervention will consist of 12 weeks of repeated, daily 20-min body immersions. | Other | Hyperthermic Baths |
Primary outcome
Seizure frequency (SF28)
Time frame: Up to 12 week after hyperthermic baths
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as SF28 in the baseline period. The seizure frequency in the treatment phase is defined as SF28 per month during the treatment period. Percent change in seizure frequency=100*(treatment SF28-baseline SF28)/baseline SF28.
2 secondary outcomes
Seizure Responder Rate
Time frame: Up to 12 week after hyperthermic baths
Seizure-free Days
Time frame: Up to 12 week after hyperthermic baths
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 6 Oct 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Hyperthermic Baths in people with 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 8 inclusion and 4 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 6 Oct 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 (SF28) (time frame: Up to 12 week after hyperthermic baths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.