Antiepileptic Drugs in Elderly Patients

Seizure, Epileptic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459597
• Other study ID #: Elderly-Antiepileptic Drugs
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: June 30, 2028

Study information

• Verified date: July 2022
• Source: Shandong University
• Contact: Wei Zhao
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2028
• Est. primary completion date: March 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Seizure, Epileptic
• Seizures

Intervention

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

Locations

Country	Name	City	State
China	Wei Zhao	Jinan	Shandong

Sponsors (4)

Lead Sponsor	Collaborator
Wei Zhao	Shandong Provincial Qianfoshan Hospital, The Affiliated Hospital of Qingdao University, The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The incidence of adverse drug reaction		Through study completion, an average of 14 days
Secondary	The frequency of seizures		Through study completion, an average of 14 days