NCT05459597|RecruitingFDA Drug
Antiepileptic Drugs in Elderly Patients
Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients
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Population Pharmacokinetics, Effectiveness and Safety of Antiepileptic Drugs in Elderly Patients
Sponsor study identifier
observational
500
1 country
1
Study Start
January 1, 2021
Actual (reported)Primary Completion
March 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)July 4, 2022
Actual (reported)July 15, 2022
Actual (reported)March 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
The use of antiepileptic drugs depends on the clinical practice.
phenytoin, carbamazepine, lamotrigine, levetiracetam, perampanel, etc. as part of routine treatment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Elderly patients with epilepsy (≥65years).
Wei Zhao
Jinan, Shandong, China
Wei Zhao
Qianfoshan Hospital
First Submitted
July 4, 2022
First Posted
July 15, 2022
Study Start
January 1, 2021
Actual (reported)Primary Completion
March 30, 2028
EstimatedAn open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Lacosamide tablets USP 200 mg, manufactured by Sun Laboratories Industries Limited, India with Vimpat (Lacosamide) 200 mg film-coated tablets, Marketing Authorisation Holder UCB Pharma S.A., Belgium, in healthy adult, human subjects under fasting condition.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 15, 2022
Record last verified: 2022-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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