Antiepileptic Drugs in Elderly Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-100
SponsorWei Zhao

About this trial

The purpose is to study the population pharmacokinetics, effectiveness and safety of antiepileptic drug (phenytoin, carbamazepine, lamotrigine, levetiracetam, parempanel, etc) in elderly patients and recommend optimized dosage regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥65 years old;

Diagnosed with epilepsy;

Using antiepileptic drugs for treatment;

Disqualifiers

Patients who are expected to die within 48 hours;

Patients with allergy to antiepileptic drugs;

Patients receiving other investigational drugs;

Other factors that the researcher considers unsuitable for inclusion.

Trial population

Elderly patients with epilepsy (≥65years).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • antiepileptic drugs

    Drug

    phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Treatment1 intervention

Trial outcomes

Primary outcomes

1

The peak plasma drug concentration of antiepileptic drugs.

To detect the peak plasma drug concentration of antiepileptic drugs.

Time frame
at (0-4) h after oral administration
2

The random plasma drug concentration of antiepileptic drugs.

To detect the random plasma drug concentration of antiepileptic drugs.

Time frame
at (4-10) h after oral administration
3

The trough plasma drug concentration of antiepileptic drugs.

To detect the trough plasma drug concentration of antiepileptic drugs.

Time frame
at (1-2) h before the next administration

Secondary outcomes

1

The incidence of adverse drug reaction

Time frame
Through study completion, an average of 14 days
2

The frequency of seizures

Time frame
Through study completion, an average of 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wei Zhao

Lead sponsor

Shandong University

Sponsor institution

Qianfoshan Hospital

Collaborator

The Second Hospital of Shandong University

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator