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Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)

NCT06719791 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-12-31

No results posted yet for this study

Summary

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

  • Epilepsy, Drug Resistant

Interventions

DRUG

Sirolimus

Oral administration is given solely for the epilepsy seizure event. Dosage: The dosage is determined based on body surface area (BSA), with 0.5 mg per dose for BSA \<1.2 m², 1 mg per dose for BSA 1.3-2.1 m², and 1.5 mg per dose for BSA \>2.2 m².

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Liankun Ren, MD · Xuanwu Hospital, Beijing

  • Zhuo Huang, PhD · Peking University School of Pharmaceutical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2027-12-01
Completion
2028-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719791 on ClinicalTrials.gov