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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06491303
Enrollment
45
Registered
2024-07-09
Start date
2024-11-01
Completion date
2025-12-01
Last updated
2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Aplastic Anemia, Epilepsy, Neutropenia, Thrombocytopenia

Keywords

Levetiracetam, Hematological effects, antiepileptic drugs, Epilepsy, Neutropenia, Thrombocytopenia

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Adult Epileptic patients of both genders aged \>18 years on mono-therapy of levetiracetam anti-epileptic drug treatment for at least six months.

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.

Design outcomes

Primary

MeasureTime frameDescription
Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsyone yearsAll 45 patients will be included within certain inclusion criteria after informed consent will be subjected to full history, general examination,systemic examination including cardiac, chest and abdominal examination will be done to detect associated or excluded conditions and Laboratory tests include complete blood count assay. The primary outcome measures to be assessed in this study is the effect of Levetiracetam(at least 6 months duration of treatment)on complete blood count including 1. Haemoglobin level. 2. Red cell count. 3. Hematocrit value. 4. M.C.V 5. M.C.H 6. M.C.H.C 7. Platelets count including MPV and PCT. 8. Total leucocytic count including neutrophils(band and segmented), lymphocytes, monocytes, basophils and eosinophils.

Contacts

Primary ContactMohammed Ha Mohammed Abdel-Rahman, MBBCh
mohamedhamoda321@gmail.com+201069387249

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026