Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Patients were on treatment for less than six months.
Patients had other conditions besides epilepsy that could affect blood parameters.
patients on treatment with other antiepileptic medications besides levetiracetam.
Trial population
Based on determining the main outcome variable, The estimated minimum required sample size is 45 patients. The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is to investigate hematological changes in adult patients with epilepsy who were treated with levetiracetam as monotherapy. Based on previous studies \[8\] the percentage of patients who their hemoglobin fell below 10g/dl while taking Levetiracetam was 8%, and based on the percentage confidence limits of 5% and a Confidence level=80%
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 2 trial groupsGroup A: Distribution of studied patients by age in years.
Group B: Distribution of studied patients by duration of levetiracetam administration in months
Trial outcomes
Primary outcomes
1
Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
All 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.
Time frame
one yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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