Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05459597

Antiepileptic Drugs in Elderly Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Seizure, Epileptic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

antiepileptic drugs

Drug

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

Primary outcomes

  1. The peak plasma drug concentration of antiepileptic drugs.

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

    To detect the peak plasma drug concentration of antiepileptic drugs.

  2. The random plasma drug concentration of antiepileptic drugs.

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

    To detect the random plasma drug concentration of antiepileptic drugs.

  3. The trough plasma drug concentration of antiepileptic drugs.

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

    To detect the trough plasma drug concentration of antiepileptic drugs.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhao

CONTACT

[email protected]

86053188383308

Sponsors and collaborators

Lead sponsor

Wei Zhao

Other

Collaborators

  • Qianfoshan Hospital
  • The Affiliated Hospital of Qingdao University
  • The Second Hospital of Shandong University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jul 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.