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Tests treatment safety and results for Epilepsy
Official title The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
ClinicalTrials.gov ID: NCT07095933
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for epilepsy.
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 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.
- 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
- Age between 18 and 60 years (inclusive), regardless of sex.
- Diagnosis of epilepsy, meeting the criteria for focal seizures or focal to bilateral tonic-clonic seizures as defined by the 2017 International...
- History of epileptic seizures lasting ≥30 seconds, accompanied by impaired awareness.
- At least 16 focal seizures during the 8-week baseline period prior to enrollment, with no seizure-free interval of 21 consecutive days.
- Findings on electroencephalography (EEG) or neuroimaging (MRI or CT) performed within 2 years prior to screening consistent with a diagnosis of focal...
You likely can't join if
- Diagnosis of primary generalized epilepsy.
- History of non-epileptic events (e.g., psychogenic non-epileptic seizures).
- Patients with only non-motor focal seizures according to the 2017 ILAE classification.
- Epilepsy with identifiable and treatable causes (e.g., metabolic disorders, intoxication, infection, space-occupying lesions, or confirmed genetic...
- Inability to accurately count seizures due to excessively frequent episodes within the 12 months prior to study drug administration.
- History of epileptic seizure clusters within the 12 months prior to study drug administration.
See the full eligibility criteria
- Age between 18 and 60 years (inclusive), regardless of sex.
- Diagnosis of epilepsy, meeting the criteria for focal seizures or focal to bilateral tonic-clonic seizures as defined by the 2017 International League Against Epilepsy (ILAE) classification.
- History of epileptic seizures lasting ≥30 seconds, accompanied by impaired awareness.
- At least 16 focal seizures during the 8-week baseline period prior to enrollment, with no seizure-free interval of 21 consecutive days.
- Findings on electroencephalography (EEG) or neuroimaging (MRI or CT) performed within 2 years prior to screening consistent with a diagnosis of focal epilepsy, and exclusion of progressive structural central nervous...
- Diagnosis of drug-resistant epilepsy, defined as failure to achieve sustained seizure freedom despite adequate trials of at least two appropriately chosen and tolerated antiseizure medications (ASMs) over a period of 2...
- Use of vagus nerve stimulation (VNS) or deep brain stimulation (DBS) is permitted, provided the device was implanted at least 5 months prior to screening, with stimulation parameters stable for at least 12 weeks before...
- Written informed consent to participate in the study, provided voluntarily by the subject.
- In the investigator's judgment, the subject is able to comply with the requirements of the study protocol, including understanding and completing seizure diaries, adhering to the visit schedule, and taking study...
- Diagnosis of primary generalized epilepsy.
- History of non-epileptic events (e.g., psychogenic non-epileptic seizures).
- Patients with only non-motor focal seizures according to the 2017 ILAE classification.
- Epilepsy with identifiable and treatable causes (e.g., metabolic disorders, intoxication, infection, space-occupying lesions, or confirmed genetic abnormalities).
- Inability to accurately count seizures due to excessively frequent episodes within the 12 months prior to study drug administration.
- History of epileptic seizure clusters within the 12 months prior to study drug administration.
- History of status epilepticus within the 12 months prior to study drug administration.
- Use of mTOR pathway inhibitors within the 12 months prior to study drug administration.
- History of cerebrovascular events (e.g., cerebral infarction, cerebral hemorrhage, or transient ischemic attack) or progressive intracranial lesions within the 6 months prior to study drug administration.
- Presence of severe uncontrolled diseases, including immunodeficiency disorders, hepatic or renal disease, acute infection, significant pulmonary dysfunction, or advanced malignancy.
- Severe cardiovascular or peripheral vascular disease, such as New York - Heart Association (NYHA) class III-IV heart failure, malignant arrhythmias (e.g., long QT syndrome, Brugada syndrome, conduction block), any other...
- History of any condition or surgery that, in the investigator's opinion, could affect absorption, distribution, or metabolism of the study drug (e.g., active gastric ulcer, ulcerative colitis, Crohn's disease...
- Any medical condition, psychiatric disorder, cognitive impairment, or intellectual disability that, in the investigator's judgment, may increase the risk to the subject or interfere with study participation.
- Laboratory abnormalities meeting any of the following criteria: alanine aminotransferase (ALT) \>2× upper limit of normal (ULN), aspartate aminotransferase (AST) \>2× ULN, alkaline phosphatase (ALP) \>2× ULN, platelet...
- Female people who test positive for pregnancy during screening or who are breastfeeding.
- History of alcohol or substance abuse within 2 years prior to study drug administration.
- Participation in any other clinical trial within 3 months prior to study drug administration, except for non-treatment clinical trials.
- Known hypersensitivity or allergy to any component of everolimus tablets.
- Current use of medications that may affect the central nervous system or the metabolism of everolimus.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, Beijing Municipality, 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.