Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-20
Brief Title:
Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None