Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-01

Brief Summary

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Low therapeutic index of established antiepileptic drugs (AEDs) coupled with better understanding of the pathophysiology of seizure has encouraged the development of several novel AEDs. The conventional antiepileptics like phenytoin, phenobarbitone, valproate and carbamazepine and newer antiepileptics like levetiracetam. are used for epilepsy. AEDs induce potentially toxic effects over a period of time which remains undetermined over very long time. Earlier studies in this regard, states uneven results about hematological (Hb%, blood cell count etc.) toxicity of AEDs.

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Detailed Description

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Epilepsy is a chronic neurologic disease that is considered the most common neurological diseases in the world and comes third after cerebrovascular and Alzheimer's disease. Epilepsy is a disorder characterized by a long-term tendency to cause epileptic seizures due to abnormal electrical activity in the brain with neurological, cognitive, psychological and social consequences . However, it is not a single disease entity but it is a collection of different kinds of seizures resulting from several mechanisms and different cause. The aim of epilepsy management is complete seizures cessation and maintenance of a good quality of life, which is affected not only by the epileptic attacks but also by the adverse effect of the drugs used .Levetiracetam (LEV) is a relatively new, broad-spectrum AED that has seen extensive use during recent years . Its mechanism of action is not completely known, but differs from those of other AEDs. LEV is described as being well tolerated, and the most common adverse effects are generally mild . Studies evaluating the effect of levetiracetam on hematological parameters have reported a spectrum of hematological abnormalities that ranges from mild thrombocytopenia or neutropenia to anemia, red cell aplasia, until bone marrow failure. Fortunately, potentially fatal hematological disorders such as aplastic anemia are very rare.

Conditions

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Neutropenia Thrombocytopenia Aplastic Anemia Anemia Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Distribution of studied patients by age in years.

Adult patients suffering of epilepsy aged 18 to 60 years old

No interventions assigned to this group

Distribution of studied patients by duration of levetiracetam administration in months

Adult patients suffering of epilepsy and receiving treatment of levetiracetam for at least 6 months

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

1. Patients were on treatment for less than six months.
2. Patients had other conditions besides epilepsy that could affect blood parameters.
3. patients on treatment with other antiepileptic medications besides levetiracetam.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes