Antiepileptic Drugs in Elderly Patients

Population Pharmacokinetics, Effectiveness and Safety of 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.

Study Overview

• Status: Recruiting
• Conditions: Seizure, Epileptic
• Intervention / Treatment: Drug: antiepileptic drugs

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Wei Zhao; Phone Number: 86053188383308; Email: zhao4wei2@hotmail.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Wei Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients with epilepsy (≥65years).

Description

Inclusion Criteria:

1. Age ≥65 years old;
2. Diagnosed with epilepsy;
3. Using antiepileptic drugs for treatment;

Exclusion Criteria:

1. Patients who are expected to die within 48 hours;
2. Patients with allergy to antiepileptic drugs;
3. Patients receiving other investigational drugs;
4. Other factors that the researcher considers unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; The use of antiepileptic drugs depends on the clinical practice.	Drug: antiepileptic drugs; phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The peak plasma drug concentration of antiepileptic drugs.	To detect the peak plasma drug concentration of antiepileptic drugs.	at (0-4) h after oral administration
The random plasma drug concentration of antiepileptic drugs.	To detect the random plasma drug concentration of antiepileptic drugs.	at (4-10) h after oral administration
The trough plasma drug concentration of antiepileptic drugs.	To detect the trough plasma drug concentration of antiepileptic drugs.	at (1-2) h before the next administration

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of adverse drug reaction	Through study completion, an average of 14 days
The frequency of seizures	Through study completion, an average of 14 days

Collaborators and Investigators

• Sponsor: Wei Zhao
• Collaborators: The Affiliated Hospital of Qingdao University; Qianfoshan Hospital; The Second Hospital of Shandong University
• Investigators: Study Chair: Wei Zhao, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): March 30, 2028
• Study Completion (Anticipated): June 30, 2028

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Anticonvulsants
• Other Study ID Numbers: Elderly-Antiepileptic Drugs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No