CDKL5 Deficiency DisorderNCT07602205
Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A PROBE Clinical Trial
A study testing Home-based hyperthermic Baths in people with CDKL5 Deficiency Disorder, run by Xuanwu Hospital, Beijing.
Trial summary
The primary objective of this research is to study the efficacy and safety of daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- CDKL5 Deficiency Disorder
- What is being tested?
- Home-based hyperthermic Baths
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A diagnosis of CDKL5 deficiency disorder, including molecular confirmation of a pathogenic CDKL5 variant and exhibiting epileptic seizures.
- Male or female participants aged 6 months to 14 years, inclusive.
- Patients presenting with drug-resistant epilepsy that seizures were uncontrolled despite the appropriate trial of at least two antiseizure medications (ASMs).
- At least 8 motor seizures during each 4 weeks in the 8-week historical seizure records preceding screening.
- Treatment regimens of 0-4 ASMs were required to be stable for at least 4 weeks before screening and throughout the intervention. Ongoing ketogenic diets were allowed if remain unchanged during screening and treatment.
- Subjects who have undergone surgical implantation of vagus nerve stimulation (VNS) will be eligible for inclusion in the study, provided they meet all of the following criteria:
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- The VNS device has been in place for at least one year prior to the screening visit;
- The stimulation parameters remain unchanged throughout the duration of the trial.
- Parents or caregivers must be able and willing to maintain an accurate and comprehensive daily electronic seizure diary throughout the duration of the study.
- Participants' legal guardians willing to provide written informed consent.
Who cannot join
- Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes.
- Participants with skin ulceration or dermatologic conditions that make bathing unsuitable.
- Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths.
- A history of seizures induced by thermal baths, or an increase in seizure frequency after thermal baths.
- Patients who presented any clinical condition that in the opinion of the principal investigator made the patient not suitable to participate in the survey.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A Prospective, Randomized, Parallel-Controlled, Open-Label, Blinded Endpoint (PROBE) Clinical Trial
The primary objective of this research is to study the efficacy and safety of daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder.
Read the detailed description
This is a prospective, randomized, open-label, blinded-endpoint study designed to evaluate the efficacy and safety of daily home-based hyperthermic bathing in participants with CDKL5 deficiency disorder. Eligible participants will be randomized in a 1:1 ratio to receive either hyperthermic baths in addition to usual antiseizure care or usual antiseizure care alone without hyperthermic baths. Efficacy will be assessed primarily by changes in epileptic seizure burden, and safety will be evaluated throughout the study period.
- Conditions
- CDKL5 Deficiency Disorder
- Being tested
- Home-based hyperthermic Baths
- Keywords
- CDKL5 Deficiency Disorder, fever, epilepsy, home-based hyperthermic baths, genotype-phenotype
- Medical subject headings
- CDKL5 deficiency disorder, Fever, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based hyperthermic BathsBehavioural
A 12-week daily home-based hyperthermic bathing intervention consisting of immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision. The intervention will be administered according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Home-based hyperthermic baths group | Experimental | Patients with CDKL5 deficiency disorder assigned to the daily home-based hyperthermic bathing group will undergo immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision. Receives: Behavioral: Home-based hyperthermic Baths |
| Control Group | No intervention | Participants assigned to the control group will not receive hyperthermic baths during the study period and will continue their usual care, including their existing antiseizure treatment regimen. Seizure frequency and safety outcomes will be assessed according to the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Responder Rate
The proportion of participants achieving at least a 50% reduction in seizure frequency from baseline during the 12-week home-based hyperthermic baths period.
Measured: Baseline to week 12 at home-based hyperthermic baths phase
Secondary outcomes (2)
Change in Seizure Frequency
Change in the frequency of epileptic seizures from baseline to the 12-week home-based hyperthermic baths period.
Measured: Baseline to week 12 at home-based hyperthermic baths phase
Seizure-free Days
Number of days without epileptic seizures during the 12-week treatment period.
Measured: Baseline to week 12 at home-based hyperthermic baths phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
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, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602205
- Sponsor's protocol ID
- 2026-161-001
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A Prospective, Randomized, Parallel-Controlled, Open-Label, Blinded Endpoint (PROBE) Clinical Trial
- ClinicalTrials.gov ID
- NCT07602205
- Acronym / sponsor ID
- 2026-161-001
- Conditions
- CDKL5 Deficiency Disorder
- Keywords
- CDKL5 Deficiency Disorder, fever, epilepsy, home-based hyperthermic baths, genotype-phenotype
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2026 (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 daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder.
Detailed description
This is a prospective, randomized, open-label, blinded-endpoint study designed to evaluate the efficacy and safety of daily home-based hyperthermic bathing in participants with CDKL5 deficiency disorder. Eligible participants will be randomized in a 1:1 ratio to receive either hyperthermic baths in addition to usual antiseizure care or usual antiseizure care alone without hyperthermic baths. Efficacy will be assessed primarily by changes in epileptic seizure burden, and safety will be evaluated throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based hyperthermic baths group | Experimental | Behavioral: Home-based hyperthermic BathsPatients with CDKL5 deficiency disorder assigned to the daily home-based hyperthermic bathing group will undergo immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision. |
| Control Group | No intervention | –Participants assigned to the control group will not receive hyperthermic baths during the study period and will continue their usual care, including their existing antiseizure treatment regimen. Seizure frequency and safety outcomes will be assessed according to the study protocol. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- A diagnosis of CDKL5 deficiency disorder, including molecular confirmation of a pathogenic CDKL5 variant and exhibiting epileptic seizures.
- Male or female participants aged 6 months to 14 years, inclusive.
- Patients presenting with drug-resistant epilepsy that seizures were uncontrolled despite the appropriate trial of at least two antiseizure medications (ASMs).
- At least 8 motor seizures during each 4 weeks in the 8-week historical seizure records preceding screening.
- Treatment regimens of 0-4 ASMs were required to be stable for at least 4 weeks before screening and throughout the intervention. Ongoing ketogenic diets were allowed if remain unchanged during screening and treatment.
Key exclusion criteria (5 listed)
- Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes.
- Participants with skin ulceration or dermatologic conditions that make bathing unsuitable.
- Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths.
- A history of seizures induced by thermal baths, or an increase in seizure frequency after thermal baths.
- Patients who presented any clinical condition that in the opinion of the principal investigator made the patient not suitable to participate in the survey.
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 |
|---|---|---|
| Home-based hyperthermic BathsA 12-week daily home-based hyperthermic bathing intervention consisting of immersion in a 40-42°C water bath for 20 minutes per session under continuous parental supervision. The intervention will be administered according to the study protocol. | Behavioural | Home-based hyperthermic baths group |
Primary outcome
Seizure Responder Rate
Time frame: Baseline to week 12 at home-based hyperthermic baths phase
The proportion of participants achieving at least a 50% reduction in seizure frequency from baseline during the 12-week home-based hyperthermic baths period.
2 secondary outcomes
Change in Seizure Frequency
Time frame: Baseline to week 12 at home-based hyperthermic baths phase
Seizure-free Days
Time frame: Baseline to week 12 at home-based hyperthermic baths phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
Liankun Ren, MD, PhD principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing Home-based hyperthermic Baths in people with CDKL5 Deficiency Disorder, run by Xuanwu Hospital, Beijing.
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 10 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liankun Ren, MD, PhD (+86 13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Responder Rate (time frame: Baseline to week 12 at home-based hyperthermic baths phase). 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 22 May 2026.