Seizure, EpilepticNCT05459597
Antiepileptic Drugs in Elderly Patients
An observational study of Seizure, Epileptic, run by Wei Zhao at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Seizure, Epileptic
- What is being tested?
- antiepileptic drugs
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jun 2028
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with epilepsy (≥65years).
Who may be able to join
- Age ≥65 years old;
- Diagnosed with epilepsy;
- Using antiepileptic drugs for treatment;
Who cannot join
- Patients who are expected to die within 48 hours;
- Patients with allergy to antiepileptic drugs;
- Patients receiving other investigational drugs;
- Other factors that the researcher considers unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wei Zhao
Jinan, Shandong
Wei Zhao, Ph.D, 86053188383308, zhao4wei2@hotmail.com
About this study
Official title: 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.
- Conditions
- Seizure, Epileptic
- Being tested
- antiepileptic drugs
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiepileptic drugsDrug
phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | The use of antiepileptic drugs depends on the clinical practice. Receives: Drug: antiepileptic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak plasma drug concentration of antiepileptic drugs.
To detect the peak plasma drug concentration of antiepileptic drugs.
Measured: 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.
Measured: 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.
Measured: at (1-2) h before the next administration
Secondary outcomes (2)
The incidence of adverse drug reaction
Measured: Through study completion, an average of 14 days
The frequency of seizures
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2021
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seizure, EpilepticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Wei Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, The Second Hospital of Shandong University, The Affiliated Hospital of Qingdao University
- Responsible party
- Sponsor-investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459597
- Sponsor's protocol ID
- Elderly-Antiepileptic Drugs
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients
- ClinicalTrials.gov ID
- NCT05459597
- Acronym / sponsor ID
- Elderly-Antiepileptic Drugs
- Conditions
- Seizure, Epileptic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wei ZhaoUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, The Second Hospital of Shandong University, The Affiliated Hospital of Qingdao University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: antiepileptic drugsThe use of antiepileptic drugs depends on the clinical practice. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with epilepsy (≥65years).
Key inclusion criteria (3 listed)
- Age ≥65 years old;
- Diagnosed with epilepsy;
- Using antiepileptic drugs for treatment;
Key exclusion criteria (4 listed)
- Patients who are expected to die within 48 hours;
- Patients with allergy to antiepileptic drugs;
- Patients receiving other investigational drugs;
- Other factors that the researcher considers unsuitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiepileptic drugsphenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment. | Drug | Treatment |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Zhao study chair
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizure, Epileptic, run by Wei Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak plasma drug concentration of antiepileptic drugs. (time frame: at (0-4) h after oral administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.