Antiepileptic Drugs in Elderly Patients

• Sponsor: Wei Zhao (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05459597
• Collaborator: Qianfoshan Hospital (Other), The Second Hospital of Shandong University (Other), The Affiliated Hospital of Qingdao University (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 89.9
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seizure, Epileptic	Drug: antiepileptic drugs

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Mar 30, 2028
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. The incidence of adverse drug reaction [Through study completion, an average of 14 days]

2. The frequency of seizures [Through study completion, an average of 14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wei Zhao	Jinan	Shandong	China

Sponsors and Collaborators

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

Investigators

• Study Chair: Wei Zhao, Qianfoshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong University
• ClinicalTrials.gov Identifier: NCT05459597
• Other Study ID Numbers: Elderly-Antiepileptic Drugs
• First Posted: Jul 15, 2022
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Seizures; Anticonvulsants

Study Results

No Results Posted as of Jul 15, 2022