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Adjunctive Everolimus Treatment of Refractory Epilepsy

NCT05613166 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-11-14

No results posted yet for this study

Summary

This project is a prospective, randomized, placebo-controlled, double-blind study that will evaluate the clinical efficacy of everolimus as an adjunctive treatment in adult patients diagnosed with refractory epilepsy.

Conditions

Interventions

DRUG

Everolimus

Everolimus will be administrated orally based on seizure events, with an administration interval longer than 24 hours. Participates with a body surface area (BSA) of \<= 1.2 m\^2, the dosage was 2.5 mg/time; for BSA 1.3-2.1 m\^2, the dosage was 5 mg/time; and for BSA \>=2.2 m\^2, the dosage was 7.5 mg/time.

DRUG

Placebo

Vitamin C

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Shengjing Hospital

    collaborator OTHER

  • National Institute on Drug Dependence, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2023-01-31
Completion
2023-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05613166 on ClinicalTrials.gov