NCT05613166

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

November 5, 2022

Last Update Submit

November 5, 2022

Conditions

Epilepsy

Keywords

everolimus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline frequency of epileptic discharge

    Comparing frequency of epileptic discharge during video-EEG monitoring after versus before treatment

    1 week

Secondary Outcomes (6)

  • Change from baseline seizure frequency

    6 months

  • Change from baseline seizure types

    6 months

  • Change from baseline frequency of seizure-free days

    6 months

  • Seizure-free rate

    3 months

  • Change from baseline occurrence of secondary generalized seizure and status epilepticus

    6 months

  • +1 more secondary outcomes

Study Arms (3)

everolimus 1h

EXPERIMENTAL

The study participants will orally receive everolimus within 1 hour and placebo at 8-9 hours after each seizure event, but with intervals longer than 24 hours.

Drug: EverolimusDrug: Placebo

everolimus 8-9h

EXPERIMENTAL

The study participants will orally receive placebo within 1 hour and everolimus at 8-9 hours after each seizure event, but with intervals longer than 24 hours.

Drug: EverolimusDrug: Placebo

placebo

PLACEBO COMPARATOR

The study participants will orally receive placebo both within 1 hour and at 8-9 hours after each seizure event, but with intervals longer than 24 hours.

Drug: Placebo

Interventions

EverolimusDRUG

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.

Also known as: Afinitor
everolimus 1heverolimus 8-9h
PlaceboDRUG

Vitamin C

everolimus 1heverolimus 8-9hplacebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of drug resistant epilepsy, with treatment of at least two approved anti-epileptic drugs (AEDs), and having at least one reported seizure per month during the 3-month baseline phase and no continuous 3-month seizure-free period.
  • Diagnosis of focal epilepsy without secondary generalization.
  • Treatment with a stable dose of AEDs that must have no drug interactions with everolimus (eg, valproic acid, topiramate, oxazepine, phenobarbital, phenytoin, and primidone) for at least 12 weeks before enrollment.

You may not qualify if:

  • History of non-drug treatment for epilepsy, eg, vagus nerve stimulation (VNS), ketogenic diet, and epilepsy surgery.
  • Severe dysfunction in kidney.
  • With significant infectious, immunologic, or oncologic comorbidity at the time of enrollment.
  • Currently taking or previously treated systemically with an mammilian target of rapamycin (mTOR) inhibitor.
  • History of seizures secondary to drug abuse, psychogenic nonepileptic seizures, or an episode of status epilepticus within 1 year before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Central Study Contacts

Weining Ma, MD.

CONTACT

86-024-96615-36316maweining1985@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2022

First Posted

November 14, 2022

Study Start

November 1, 2022

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

CN(1)