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.
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.
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.