NCT05459597

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jan 2021Jun 2028

Study Start

First participant enrolled

January 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

7.2 years

First QC Date

July 4, 2022

Last Update Submit

July 14, 2022

Conditions

Seizure, Epileptic

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • The incidence of adverse drug reaction

    Through study completion, an average of 14 days

  • The frequency of seizures

    Through study completion, an average of 14 days

Study Arms (1)

Treatment

The use of antiepileptic drugs depends on the clinical practice.

Drug: antiepileptic drugs

Interventions

antiepileptic drugsDRUG

phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.

Treatment

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients with epilepsy (≥65years).

You may qualify if:

  • Age ≥65 years old;
  • Diagnosed with epilepsy;
  • Using antiepileptic drugs for treatment;

You may not qualify if:

  • Patients who are expected to die within 48 hours;
  • Patients with allergy to antiepileptic drugs;
  • Patients receiving other investigational drugs;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei Zhao

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Seizures

Interventions

Anticonvulsants

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Wei Zhao

    Qianfoshan Hospital

    STUDY CHAIR

Central Study Contacts

Wei Zhao

CONTACT

86053188383308zhao4wei2@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of department of clinical pharmacy and pharmacology

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 15, 2022

Study Start

January 1, 2021

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

CN(1)