NeutropeniaNCT06491303
Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
An observational study of Neutropenia and Thrombocytopenia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neutropenia, Thrombocytopenia, Aplastic Anemia
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study 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%
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
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.
Read the 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.
- Conditions
- Neutropenia, Thrombocytopenia, Aplastic Anemia, Anemia, Epilepsy
- Keywords
- Levetiracetam, Hematological effects, antiepileptic drugs, Epilepsy, Neutropenia, Thrombocytopenia
- Medical subject headings
- Neutropenia, Thrombocytopenia, Anemia, Aplastic, Anemia, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Distribution of studied patients by age in years. | Adult patients suffering of epilepsy aged 18 to 60 years old | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Haemoglobin level.
- Red cell count.
- Hematocrit value.
- M.C.V
- M.C.H
- M.C.H.C
- Platelets count including MPV and PCT.
- Total leucocytic count including neutrophils(band and segmented), lymphocytes, monocytes, basophils and eosinophils.
Measured: one years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa AA Khaled, Assiut University
- Investigators
- Safa Abdel-Sattar, professor, Study director, Assiut UniversityRania Mohamed, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491303
- Sponsor's protocol ID
- Levetiracetam
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Attilakos A, Dinopoulos A, Paschalidou M, Tsirouda M, Karalexi M, Prasouli A, Garoufi A. Long-term effect of levetiracetam monotherapy on haematological parameters in children with epilepsy: A prospective study. Epilepsy Res. 2018 Sep;145:160-162. doi: 10.1016/j.eplepsyres.2018.07.001. Epub 2018 Jul 6.
PubMed 30007241Dinopoulos A, Attilakos A, Paschalidou M, Tsirouda M, Garoufi A, Moustaki M, Siafakas N, Papaevangelou V. Short-term effect of levetiracetam monotherapy on haematological parameters in children with epilepsy: a prospective study. Epilepsy Res. 2014 May;108(4):820-3. doi: 10.1016/j.eplepsyres.2014.02.006. Epub 2014 Feb 19.
PubMed 24630047
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
- ClinicalTrials.gov ID
- NCT06491303
- Acronym / sponsor ID
- Levetiracetam
- Conditions
- Neutropenia, Thrombocytopenia, Aplastic Anemia, Anemia, Epilepsy
- Keywords
- Levetiracetam, Hematological effects, antiepileptic drugs, Epilepsy, Neutropenia, Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distribution of studied patients by age in years. | – | –Adult patients suffering of epilepsy aged 18 to 60 years old |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study 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%
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
Time frame: one years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 30007241Attilakos A, Dinopoulos A, Paschalidou M, Tsirouda M, Karalexi M, Prasouli A, Garoufi A. Long-term effect of levetiracetam monotherapy on haematological parameters in children with epilepsy: A prospective study. Epilepsy Res. 2018 Sep;145:160-162. doi: 10.1016/j.eplepsyres.2018.07.001. Epub 2018 Jul 6.
- Background: PubMed 24630047Dinopoulos A, Attilakos A, Paschalidou M, Tsirouda M, Garoufi A, Moustaki M, Siafakas N, Papaevangelou V. Short-term effect of levetiracetam monotherapy on haematological parameters in children with epilepsy: a prospective study. Epilepsy Res. 2014 May;108(4):820-3. doi: 10.1016/j.eplepsyres.2014.02.006. Epub 2014 Feb 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safa Abdel-Sattar, professor study director
Assiut University
Rania Mohamed, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia and Thrombocytopenia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Ha Mohammed Abdel-Rahman, MBBCh (+201069387249, mohamedhamoda321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy (time frame: one years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06491303, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.