Antiepileptic Drugs in Elderly Patients

Recruiting

• Conditions: Seizure, Epileptic
• Interventions: Drug: antiepileptic drugs

• Registration Number: NCT05459597
• Lead Sponsor: Wei Zhao

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15
• Primary Completion: 2028-03-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	antiepileptic drugs	The use of antiepileptic drugs depends on the clinical practice.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The frequency of seizures	Through study completion, an average of 14 days
The incidence of adverse drug reaction	Through study completion, an average of 14 days

Trial Locations

Locations (1)

Wei Zhao; 🇨🇳 Jinan, Shandong, China