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Recruiting NCT05459597

Antiepileptic Drugs in Elderly Patients

— Observational Seizure, Epileptic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: antiepileptic drugs.
Who it may be relevant to
Registry conditions: Seizure, Epileptic. Basic parameters: 65 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients

Overview

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.

Interventions

  • Drug antiepileptic drugs
    phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.

Primary outcome measures

  • The peak plasma drug concentration of antiepileptic drugs. [Time frame: at (0-4) h after oral administration]
  • The random plasma drug concentration of antiepileptic drugs. [Time frame: at (4-10) h after oral administration]
  • The trough plasma drug concentration of antiepileptic drugs. [Time frame: at (1-2) h before the next administration]
Secondary outcome measures (2)
  • The incidence of adverse drug reaction [Time frame: Through study completion, an average of 14 days]
  • The frequency of seizures [Time frame: Through study completion, an average of 14 days]

Eligibility criteria

Inclusion criteria

  • Age ≥65 years old;
  • Diagnosed with epilepsy;
  • Using antiepileptic drugs for treatment;

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Wei Zhao — Jinan

Identifiers

NCT: NCT05459597 · Elderly-Antiepileptic Drugs

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗