Actively Recruiting
Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)
Led by Xuanwu Hospital, Beijing · Updated on 2024-12-31
15
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
P
Peking University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the clinical efficacy of sirolimus 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
Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Diagnosed with focal seizures or focal seizures progressing to bilateral tonic-clonic seizures according to 2017 ILAE criteria
- Diagnosed with refractory epilepsy, with ineffective treatment using at least two anti-epileptic drugs for 2 years
- Stable doses of current anti-epileptic drugs for at least 12 weeks before enrollment and no drug interaction with sirolimus
- Seizure duration of at least 1 minute with sensory impairment
- At least 6 focal seizures within 12 weeks prior to enrollment
- EEG or MRI/CT results within the past 2 years confirming focal epilepsy diagnosis
- Use of vagus nerve stimulation or deep brain stimulation permitted if implanted at least 5 months ago and stable for 12 weeks before enrollment
- Signed informed consent
You will not qualify if you...
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations
- Psychogenic non-epileptic seizures within the past 12 months
- Treatable causes of epilepsy such as metabolic disorders, toxicity, infections, space occupying lesions, or identified genetic abnormalities
- Patients with only non-motor focal seizures
- Seizure clusters within the past 12 months
- Tonic-clonic status epilepticus within the past 12 months
- Major medical illnesses including cerebrovascular events within 6 months, progressive intracranial lesions
- Severe uncontrolled diseases such as immunodeficiency, liver or kidney diseases, acute infections, or advanced tumors
- Severe cardiovascular or peripheral vascular diseases including NYHA Class III-IV, malignant arrhythmias, significant ECG abnormalities, or recent myocardial infarction
- Medical conditions or surgeries affecting drug absorption, distribution, or metabolism, or difficulty swallowing
- Medical, mental health, cognitive, or intellectual conditions that increase risk or interfere with participation
- Severe allergic reactions or hypersensitivity to sirolimus components
- Laboratory abnormalities including ALT, AST, ALP greater than 2 times upper limit of normal, platelet count below 80 x10^9/L, neutrophil count below 1.8 x10^9/L, or creatinine clearance below 30 mL/min
- Pregnancy, childbirth, or lactation
- Alcohol abuse or drug misuse within 2 years prior to medication
- Participation in another clinical study within 3 months
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, China
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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