Efficacy and Safety Evaluation of Hyperthermic Baths in the Treatment of Seizures in CDKL5 Deficiency Disorder

NCT06447675 | Completed DMC

• 1 other identifier: 2024-111-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CDKL5 Deficiency Disorder

Keywords

Hyperthermic Baths; Drug Resistant Epilepsy; CDKL5

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 week after hyperthermic baths

Secondary Outcomes (2)

• Seizure Responder Rate

  Up to 12 week after hyperthermic baths

• Seizure-free Days

  Up to 12 week after hyperthermic baths

Study Arms (1)

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.

Other: Hyperthermic Baths

Interventions

Hyperthermic Baths OTHER

The intervention will consist of 12 weeks of repeated, daily 20-min body immersions.

Hyperthermic Baths

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Liankun Ren, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: September 20, 2024
• Primary Completion: June 25, 2025
• Study Completion: September 30, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)