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

NCT ID: NCT06447675

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2025-09-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperthermic Baths

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.

Group Type: EXPERIMENTAL

Hyperthermic Baths

Intervention Type: OTHER

The intervention will consist of 12 weeks of repeated (2x/day) 20-min body immersions.

Interventions

Hyperthermic Baths

The intervention will consist of 12 weeks of repeated (2x/day) 20-min body immersions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Liankun_Ren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liankun Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2024-111-002

Identifier Type: -

Identifier Source: org_study_id