Antiepileptic Efficacy and SafetyNCT07535736
Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury
An observational study of Antiepileptic Efficacy and Safety and Brain Injuries, run by Assiut University.
Trial summary
To evaluate the effectiveness and safety of anti-epileptic drugs in the prevention of early and late post-traumatic seizures among patients with trauma brain injury Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antiepileptic Efficacy and Safety, Brain Injuries
- What is being tested?
- Anti-Epileptic
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Population: Patients with TBI admitted to the hospital and evaluated clinically and radiologically on admission. A complete assessment will include: * Medical history (age, gender). * Physical examination (temperature, blood pressure, heart rate, respiratory rate, chest auscultation) * Glasgow Coma Scale (GCS). * Laboratory tests (complete blood count, sodium, potassium, blood urea nitrogen, creatinine, hepatic profile). * Brain computed tomography (CT). * Clinical monitoring, including antiepileptic drug dosing, adverse events, and mortality during hospitalisation.
Who may be able to join
- Patients with a confirmed diagnosis of traumatic brain injury (clinical and/or radiological), including both surgical and conservative management
- Admission within 24 hours of injury
- Eligible for antiepileptic prophylaxis according to clinical guidelines
- Written informed consent obtained.
Who cannot join
- Pre-existing epilepsy or seizure disorder.
- Seizure episode before or during admission unrelated to acute TBI.
- Prior use of antiepileptic drugs before admission.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Hepatic failure.
- Pregnancy or lactation.
- Known hypersensitivity to antiepileptic drugs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury
To evaluate the effectiveness and safety of anti-epileptic drugs in the prevention of early and late post-traumatic seizures among patients with trauma brain injury
Read the detailed description
Traumatic brain injury (TBI) is one of the leading causes of death and disabilities worldwide. It has been estimated that 64-74 million individuals experience TBI from all causes each year. According to the Centers for Disease Control and Prevention (CDC), an estimated 1.7 million people sustain a TBI every year in the USA.
TBI can be associated with chronic consequences such as physical and psychological disorders. In 2021, there were over 69,000 deaths because of TBI in the USA, with about 190 TBI-related deaths every day. The risk of having a TBI is highest among adolescents, young adults, and older people.
Post-traumatic seizures can be classified into immediate, that is, occurring within the first 24 hours; early, occurring within 1-7 days of life; and late, if seizures occur after 7 days of life. Prophylactic use of anti-epileptic drugs during the first 7 days is protective against early seizures. A lower incidence of seizures was observed in patients who received anti-epileptic prophylaxis. The current guidelines for post-TBI seizure prophylaxis emphasise the effectiveness of seizure control, and phenytoin and levetiracetam are frequently prescribed.
Levetiracetam is a new antiepileptic drug that is used for prophylaxis in post-traumatic brain injury. Levetiracetam has low plasma protein binding and a lower risk of drug interactions and adverse events. Levetiracetam's major metabolic pathway is hydrolysis, not via CYP450. However, the drug is eliminated via the kidneys, so patients who are critically ill or suffer from renal insufficiency may require dosage adjustment. Therapeutic drug monitoring may be required in complicated cases. A few side effects associated with levetiracetam include headache, nausea, vomiting, drowsiness, dizziness, and behavioural changes.
Although current guidelines recommend levetiracetam for post-TBI seizure prophylaxis, there is no available data regarding its effectiveness outcomes at Assiut University Trauma Hospital. This highlights the need for a local clinical evaluation to assess prescribing practices and patient outcomes in this setting. Therefore, this study aimed to evaluate the effectiveness of anti-epileptic drugs compared with the control group in preventing early and late post-traumatic seizures in patients with TBI at Assiut University Trauma Hospital.
- Conditions
- Antiepileptic Efficacy and Safety, Brain Injuries
- Being tested
- Anti-Epileptic
- Keywords
- Anti-epileptic, Brain Injury, Efficacy, Safety, Trauma
- Medical subject headings
- Brain Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-EpilepticDrug
Also called Anti-Epileptic Drug: Anti-epileptic (administered for 3 months)
The anti-epileptic drugs will take three months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A will take the antiepileptic drug for prophylaxis, in addition to the standard drugs for traumatic brain injury, for 3 months. Receives: Drug: Anti-Epileptic | |
| Group B(control group) | Group B: The control group will take the standard treatment for traumatic brain injury for 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of seizure
Number of documented seizure episodes per participant, as recorded by clinical observation during the follow-up period (3 months).
Measured: 3 months
Secondary outcomes (3)
Assess neurological outcomes
Assess the neurolgical outcomes by using the Glasgow Outcome Scale (GOS) at discharge
Measured: during the 3 months
Assess in-hospital mortality rates
To evaluate in-hospital mortality rates in both groups.
Measured: During hospitalization (assessed up to 7 days)]
Escalation of anti-epileptic therapy
Need for escalation of anti-epileptic therapy
Measured: During the 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Antiepileptic Efficacy and SafetyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geabel Abdullah Ahmed Al-Qubli, Assiut University
- Investigators
- Mohammed A Taghyan, PhD, Study chair, Assiut UniversityAhmed A Ismail, PhD, Study director, Assiut UniversityIsmail A Taha, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535736
- Sponsor's protocol ID
- 2026
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng SY, Lee AYW. Traumatic Brain Injuries: Pathophysiology and Potential Therapeutic Targets. Front Cell Neurosci. 2019 Nov 27;13:528. doi: 10.3389/fncel.2019.00528. eCollection 2019.
PubMed 31827423Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung YC, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM, Rosenfeld JV, Park KB. Estimating the global incidence of traumatic brain injury. J Neurosurg. 2018 Apr 27;130(4):1080-1097. doi: 10.3171/2017.10.JNS17352. Print 2019 Apr 1.
PubMed 29701556Faul M, Wald MM, Xu L, Coronado VG. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths, 2002-2006. 2010.
Stocchetti N, Zanier ER. Chronic impact of traumatic brain injury on outcome and quality of life: a narrative review. Crit Care. 2016 Jun 21;20(1):148. doi: 10.1186/s13054-016-1318-1.
PubMed 27323708Centers for Disease Control and Prevention. National center for health statistics: mortality data on CDC WONDER. https://wonder.cdc.gov/mcd.html 2026.
Bruns J Jr, Hauser WA. The epidemiology of traumatic brain injury: a review. Epilepsia. 2003;44(s10):2-10. doi: 10.1046/j.1528-1157.44.s10.3.x.
PubMed 14511388han A, Muntaha ST, Ayaz H, Tariq A, Mughal H. Use Of Anti-Epileptics For Seizure Prophylaxis After Traumatic Brain Injury In The Pediatric Population. Journal of Rawalpindi Medical College. 2024;28(4).
Khan SA, Bhatti SN, Khan AA, Khan Afridi EA, Muhammad G, Gul N, Zadran KK, Alam S, Aurangzeb A. Comparison Of Efficacy Of Phenytoin And Levetiracetam For Prevention Of Early Post Traumatic Seizures. J Ayub Med Coll Abbottabad. 2016 Jul-Sep;28(3):455-460.
PubMed 28712212Surtees TL, Kumar I, Garton HJL, Rivas-Rodriguez F, Parmar H, McCaffery H, Riebe-Rodgers J, Shellhaas RA. Levetiracetam Prophylaxis for Children Admitted With Traumatic Brain Injury. Pediatr Neurol. 2022 Jan;126:114-119. doi: 10.1016/j.pediatrneurol.2021.10.009. Epub 2021 Oct 19.
PubMed 34839268Malison N. Anti-epileptic for seizure prophylaxis in traumatic brain injury patients. The Bangkok Medical Journal. 2017;13(2):87-.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07535736
- Acronym / sponsor ID
- 2026
- Conditions
- Antiepileptic Efficacy and Safety, Brain Injuries
- Keywords
- Anti-epileptic, Brain Injury, Efficacy, Safety, Trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
To evaluate the effectiveness and safety of anti-epileptic drugs in the prevention of early and late post-traumatic seizures among patients with trauma brain injury
Detailed description
Traumatic brain injury (TBI) is one of the leading causes of death and disabilities worldwide. It has been estimated that 64-74 million individuals experience TBI from all causes each year. According to the Centers for Disease Control and Prevention (CDC), an estimated 1.7 million people sustain a TBI every year in the USA.
TBI can be associated with chronic consequences such as physical and psychological disorders. In 2021, there were over 69,000 deaths because of TBI in the USA, with about 190 TBI-related deaths every day. The risk of having a TBI is highest among adolescents, young adults, and older people.
Post-traumatic seizures can be classified into immediate, that is, occurring within the first 24 hours; early, occurring within 1-7 days of life; and late, if seizures occur after 7 days of life. Prophylactic use of anti-epileptic drugs during the first 7 days is protective against early seizures. A lower incidence of seizures was observed in patients who received anti-epileptic prophylaxis. The current guidelines for post-TBI seizure prophylaxis emphasise the effectiveness of seizure control, and phenytoin and levetiracetam are frequently prescribed.
Levetiracetam is a new antiepileptic drug that is used for prophylaxis in post-traumatic brain injury. Levetiracetam has low plasma protein binding and a lower risk of drug interactions and adverse events. Levetiracetam's major metabolic pathway is hydrolysis, not via CYP450. However, the drug is eliminated via the kidneys, so patients who are critically ill or suffer from renal insufficiency may require dosage adjustment. Therapeutic drug monitoring may be required in complicated cases. A few side effects associated with levetiracetam include headache, nausea, vomiting, drowsiness, dizziness, and behavioural changes.
Although current guidelines recommend levetiracetam for post-TBI seizure prophylaxis, there is no available data regarding its effectiveness outcomes at Assiut University Trauma Hospital. This highlights the need for a local clinical evaluation to assess prescribing practices and patient outcomes in this setting. Therefore, this study aimed to evaluate the effectiveness of anti-epileptic drugs compared with the control group in preventing early and late post-traumatic seizures in patients with TBI at Assiut University Trauma Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Anti-EpilepticGroup A will take the antiepileptic drug for prophylaxis, in addition to the standard drugs for traumatic brain injury, for 3 months. |
| Group B(control group) | – | –Group B: The control group will take the standard treatment for traumatic brain injury for 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population: Patients with TBI admitted to the hospital and evaluated clinically and radiologically on admission. A complete assessment will include: * Medical history (age, gender). * Physical examination (temperature, blood pressure, heart rate, respiratory rate, chest auscultation) * Glasgow Coma Scale (GCS). * Laboratory tests (complete blood count, sodium, potassium, blood urea nitrogen, creatinine, hepatic profile). * Brain computed tomography (CT). * Clinical monitoring, including antiepileptic drug dosing, adverse events, and mortality during hospitalisation.
Key inclusion criteria (4 listed)
- Patients with a confirmed diagnosis of traumatic brain injury (clinical and/or radiological), including both surgical and conservative management
- Admission within 24 hours of injury
- Eligible for antiepileptic prophylaxis according to clinical guidelines
- Written informed consent obtained.
Key exclusion criteria (7 listed)
- Pre-existing epilepsy or seizure disorder.
- Seizure episode before or during admission unrelated to acute TBI.
- Prior use of antiepileptic drugs before admission.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Hepatic failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-EpilepticAlso: Anti-Epileptic Drug: Anti-epileptic (administered for 3 months)The anti-epileptic drugs will take three months | Drug | Group A |
Primary outcome
Incidence of seizure
Time frame: 3 months
Number of documented seizure episodes per participant, as recorded by clinical observation during the follow-up period (3 months).
3 secondary outcomes
Assess neurological outcomes
Time frame: during the 3 months
Assess in-hospital mortality rates
Time frame: During hospitalization (assessed up to 7 days)]
Escalation of anti-epileptic therapy
Time frame: During the 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 31827423Ng SY, Lee AYW. Traumatic Brain Injuries: Pathophysiology and Potential Therapeutic Targets. Front Cell Neurosci. 2019 Nov 27;13:528. doi: 10.3389/fncel.2019.00528. eCollection 2019.
- Background: PubMed 29701556Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung YC, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM, Rosenfeld JV, Park KB. Estimating the global incidence of traumatic brain injury. J Neurosurg. 2018 Apr 27;130(4):1080-1097. doi: 10.3171/2017.10.JNS17352. Print 2019 Apr 1.
- BackgroundFaul M, Wald MM, Xu L, Coronado VG. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths, 2002-2006. 2010.
- Background: PubMed 27323708Stocchetti N, Zanier ER. Chronic impact of traumatic brain injury on outcome and quality of life: a narrative review. Crit Care. 2016 Jun 21;20(1):148. doi: 10.1186/s13054-016-1318-1.
- BackgroundCenters for Disease Control and Prevention. National center for health statistics: mortality data on CDC WONDER. https://wonder.cdc.gov/mcd.html 2026.
- Background: PubMed 14511388Bruns J Jr, Hauser WA. The epidemiology of traumatic brain injury: a review. Epilepsia. 2003;44(s10):2-10. doi: 10.1046/j.1528-1157.44.s10.3.x.
- Backgroundhan A, Muntaha ST, Ayaz H, Tariq A, Mughal H. Use Of Anti-Epileptics For Seizure Prophylaxis After Traumatic Brain Injury In The Pediatric Population. Journal of Rawalpindi Medical College. 2024;28(4).
- Background: PubMed 28712212Khan SA, Bhatti SN, Khan AA, Khan Afridi EA, Muhammad G, Gul N, Zadran KK, Alam S, Aurangzeb A. Comparison Of Efficacy Of Phenytoin And Levetiracetam For Prevention Of Early Post Traumatic Seizures. J Ayub Med Coll Abbottabad. 2016 Jul-Sep;28(3):455-460.
- Background: PubMed 34839268Surtees TL, Kumar I, Garton HJL, Rivas-Rodriguez F, Parmar H, McCaffery H, Riebe-Rodgers J, Shellhaas RA. Levetiracetam Prophylaxis for Children Admitted With Traumatic Brain Injury. Pediatr Neurol. 2022 Jan;126:114-119. doi: 10.1016/j.pediatrneurol.2021.10.009. Epub 2021 Oct 19.
- BackgroundMalison N. Anti-epileptic for seizure prophylaxis in traumatic brain injury patients. The Bangkok Medical Journal. 2017;13(2):87-.
- Individual participant dataSharing planned: No
Related trials for Antiepileptic Efficacy and Safety
RecruitingObservational study
Antiepileptic Drugs in Elderly Patients
Seizure, Epileptic
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.
Mohammed A Taghyan, PhD study chair
Assiut University
Ahmed A Ismail, PhD study director
Assiut University
Ismail A Taha, PhD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Antiepileptic Efficacy and Safety and Brain Injuries, 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geabel Al-Qubli, Master candidate (01034732278, geabelalqubli1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of seizure (time frame: 3 months). 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 NCT07535736, which also lists 10 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 17 Apr 2026.