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.
Full Title of Study: “Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients”
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 30, 2028
Interventions
- Drug: antiepileptic drugs
- phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.
Arms, Groups and Cohorts
- Treatment
- The use of antiepileptic drugs depends on the clinical practice.
Clinical Trial Outcome Measures
Primary Measures
- 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.
- 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.
- 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 Measures
- 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
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 65 Years
Maximum Age: 100 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Wei Zhao
- Collaborator
- Qianfoshan Hospital
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Wei Zhao, Head of department of clinical pharmacy and pharmacology – Shandong University
- Overall Official(s)
- Wei Zhao, Study Chair, Qianfoshan Hospital
- Overall Contact(s)
- Wei Zhao, 86053188383308, zhao4wei2@hotmail.com
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