The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy

Sponsor
Xuanwu Hospital, Beijing
Study ID
NCT07095933
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    Oral administration is given solely for the epilepsy seizure event. Dosage: The dosage is determined based on body surface area (BSA), with 2.5 mg per dose for BSA \<1.2 m², 5 mg per dose for BSA 1.3-2.1 m², and 7.5 mg per dose for BSA \>2.2 m².

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Everolimus
    All subjects will receive the experimental drug.

Primary Outcome Measure

Percent Change From Baseline in Seizure Frequency Per 28 Days [ Time Frame: assessed per 28 days during the treatment until the end of 12-week treatment. ]

Central Contacts

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