Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)
ConditionEpilepsy, Drug Resistant
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
Qualifiers
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 effectiveness for 2 years. No drug interaction between current AEDs and sirolomus, and a stable dose for at least 12 weeks prior to enrollment.
Seizure duration ≥1 minute, with accompanying sensory impairment.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sirolimus
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
Peking University
Collaborator
Source ClinicalTrials.gov