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New treatment option for Epilepsy, Drug Resistant
Official title Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)
ClinicalTrials.gov ID: NCT06719791
What this study is testing
What is Sirolimus?
Sirolimus is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for epilepsy, drug resistant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 18-60 years of age.
- Meet the 2017 International League Against Epilepsy (ILAE) diagnostic criteria for for focal seizures or focal seizures progressing to bilateral...
- Diagnosed with refractory epilepsy, having used at least two AEDs without how well it works for 2 years. No drug interaction between current AEDs and...
- Seizure duration ≥1 minute, with accompanying sensory impairment.
- At least 6 focal seizures within the 12 weeks preceding enrollment.
You likely can't join if
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations
- Psychogenic non-epileptic seizures within 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, as classified by the 2017 ILAE.
- Seizure clusters within the 12 months.
- Tonic-clonic status epilepticus within12 months.
See the full eligibility criteria
- 18-60 years of age.
- Meet the 2017 International League Against Epilepsy (ILAE) diagnostic criteria for for focal seizures or focal seizures progressing to bilateral tonic-clonic seizures.
- Diagnosed with refractory epilepsy, having used at least two AEDs without how well it works for 2 years. No drug interaction between current AEDs and sirolomus, and a stable dose for at least 12 weeks prior to...
- Seizure duration ≥1 minute, with accompanying sensory impairment.
- At least 6 focal seizures within the 12 weeks preceding enrollment.
- EEG or MRI/CT results within the past 2 years, confirming the diagnosis of focal epilepsy.
- The use of vagus nerve stimulation (VNS) and deep brain stimulation (DBS) is permitted, need to implant at least 5 months and stable for at least 12 weeks before enrollment.The parameters should keep unchanged until the...
- Informed consent signed.
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations
- Psychogenic non-epileptic seizures within 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, as classified by the 2017 ILAE.
- Seizure clusters within the 12 months.
- Tonic-clonic status epilepticus within12 months.
- Free of major medical illnesses including:
- Cerebrovascular events within the past 6 months, including cerebral infarction, cerebral hemorrhage, and transient ischemic attack, or those with progressive intracranial lesions.
- Severe uncontrolled diseases, such as immunodeficiency disorders, liver or kidney diseases, acute infections, or advanced-stage tumors.
- Severe cardiovascular or peripheral vascular diseases, such as those classified as NYHA Class III-IV, or those with malignant arrhythmias (e.g., Long QT syndrome, Brugada syndrome, and conduction block), or any other...
- Participants with a history of medical conditions or surgeries that, in the investigator's judgment, could affect the absorption, distribution, or metabolism of the study drug (e.g., active peptic ulcers, ulcerative...
- Participants with any medical condition, mental health status, cognitive impairment, or intellectual disability that the investigator believes could increase the risk to the participant or interfere with their ability...
- Severe allergic reactions to any component of sirolimus, or have hypersensitivity.
- Participants meeting any of the following laboratory criteria: alanine aminotransferase (ALT) \>2× upper limit of normal (ULN), aspartate aminotransferase (AST) \>2× ULN, alkaline phosphatase (ALP) \>2× ULN, platelet...
- In the period of pregnancy, childbirth, lactation.
- Alcohol abuse or drug misuse within 2 years prior to medication.
- Participation in another clinical study within 3 months;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.