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RECRUITING
NCT06719791
EARLY_PHASE1

Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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.

Official title: The Safety and Efficacy Evaluation of Sirolomus as an Adjunctive Treatment for Focal Refractory Epilepsy: A Pilot Study

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-12-23

Completion Date

2028-12-01

Last Updated

2024-12-31

Healthy Volunteers

No

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.

Locations (1)

Xuanwu Hospital

Beijing, China