Actively Recruiting
The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
Led by Xuanwu Hospital, Beijing · Updated on 2026-04-07
5
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the clinical efficacy of everolimus as an adjunctive therapy for refractory epilepsy. The significance lies in addressing whether the mTOR inhibitor sirolimus has antiepileptic adjunctive effects for a broader range of patients with refractory epilepsy, with the hope of providing a new mTOR-targeted antiepileptic adjunctive medication regimen that is administered only during epileptic events and can be widely used for various types of refractory epilepsy.
CONDITIONS
Official Title
The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years, any sex
- Diagnosis of focal epilepsy or focal to bilateral tonic-clonic seizures as per 2017 ILAE classification
- History of epileptic seizures lasting at least 30 seconds with impaired awareness
- At least 16 focal seizures in the 8 weeks prior to enrollment without 21 consecutive seizure-free days
- EEG or MRI/CT within 2 years confirming focal epilepsy and excluding progressive CNS lesions or encephalopathy
- Drug-resistant epilepsy defined as failure of at least two appropriate antiseizure medications over 2 years
- Stable dose of existing antiseizure medications with no known interaction with everolimus for at least 12 weeks
- Use of vagus nerve stimulation or deep brain stimulation permitted if implanted at least 5 months prior, with stable settings for 12 weeks
- Ability and willingness to comply with study requirements and provide informed consent
You will not qualify if you...
- Primary generalized epilepsy diagnosis
- History of non-epileptic events such as psychogenic seizures
- Only non-motor focal seizures as per 2017 ILAE classification
- Epilepsy caused by treatable conditions like metabolic disorders or infections
- Inability to accurately count seizures due to very frequent episodes within the past 12 months
- History of seizure clusters or status epilepticus within the past 12 months
- Use of mTOR inhibitors within the past 12 months
- Cerebrovascular events or progressive intracranial lesions within 6 months
- Severe uncontrolled diseases including immunodeficiency, hepatic or renal disease, acute infection, lung dysfunction, or advanced cancer
- Severe cardiovascular or peripheral vascular disease including recent myocardial infarction or significant arrhythmias
- Conditions or surgeries affecting drug absorption or metabolism, or difficulty swallowing
- Medical, psychiatric, cognitive, or intellectual conditions that increase risk or interfere with participation
- Laboratory abnormalities exceeding specified thresholds for liver enzymes, blood counts, or kidney function
- Positive pregnancy test or breastfeeding
- Alcohol or substance abuse within 2 years
- Participation in other clinical trials within 3 months except non-interventional studies
- Known allergy to everolimus or its components
- Current use of medications affecting the central nervous system or everolimus metabolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
L
Liankun Ren, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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