Focal-Onset SeizuresENGAGENCT07793396
Prospective Study of Eslicarbazepine in Adults With Focal-Onset Seizures
An observational study of Focal-Onset Seizures, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
This prospective multicenter observational study will evaluate the effectiveness, safety, tolerability, and impact on quality of life of eslicarbazepine in adults with focal-onset seizures in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal-Onset Seizures
- What is being tested?
- Eslicarbazepine acetate
- Type of treatment
- Pill or oral medicine
- How many people
- 1,500 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Dec 2025to 31 Dec 2026
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of approximately 1,500 adult male and female patients with diagnosed focal-onset (partial-onset) seizures across multiple institutes/hospitals in Pakistan. Participants will include newly diagnosed, treatment-naïve patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects. Eslicarbazepine treatment will be initiated or switched at the discretion of the treating physician in accordance with routine clinical practice and applicable prescribing information.
Who may be able to join
- Adult patients (aged at least 18 years) with diagnosed partial-onset seizures.
- Newly diagnosed (treatment-naïve) or previously treated with Carbamazepine or Oxcarbazepine and inadequately controlled or intolerant.
- Patient or Legal Representative is willing and able to provide informed consent, or, in the absence of a legal representative, an Independent Healthcare Professional provides authorization for patient enrolment.
Who cannot join
- Any hypersensitivity to Eslicarbazepine.
- Female patients who are pregnant or lactating.
- Patients who have a contraindication to the medicine or any component of prescribed therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Safia Assistant Professor Neurology, FCPS Neurology, PhD Scholar contact
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Safia Assistant Professor Neurology, FCPS Neurology, PhD Scholar, +92-301-4154276, safiabano@kemu.edu.pk
Safia Assistant Professor Neurology, FCPS Neurology, PhD Scholar, safiabano@kemu.edu.pk
About this study
Official title: A Prospective, Real-World Evidence, Multicenter Study to Evaluate the Efficacy and Safety of Eslicarbazepine in Managing Epilepsy
This prospective multicenter observational study will evaluate the effectiveness, safety, tolerability, and impact on quality of life of eslicarbazepine in adults with focal-onset seizures in routine clinical practice. Participants will include newly diagnosed patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects. Treatment with eslicarbazepine will be initiated or changed at the discretion of the treating physician in accordance with routine clinical practice. Participants will be followed for 3 months.
Read the detailed description
This prospective, multicenter observational study will assess the effectiveness, safety, and tolerability of eslicarbazepine in adults with focal-onset epilepsy, including newly diagnosed patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects.
Treatment decisions, including the decision to initiate eslicarbazepine or switch from another antiseizure medication, will be made by the treating physician according to routine clinical practice and the approved product information. The study will therefore observe outcomes associated with eslicarbazepine use without assigning participants to treatment.
Eslicarbazepine will be administered orally once daily. Newly diagnosed patients will typically start at 400 mg/day and increase to 800 mg/day after one week. Patients switching from carbamazepine or oxcarbazepine may start at 400-600 mg/day according to clinical judgment and may undergo an overnight switch or cross-titration. If clinically indicated and tolerated, the dose may be increased to a maximum of 1600 mg/day. Dose adjustments will be guided by tolerability, seizure control, and adverse-event monitoring.
Participants will be assessed at baseline, Day 7, and Month 3. Data collected will include demographic and clinical information, concomitant medications, seizure occurrence and frequency, quality of life using the Patient Quality of Life in Epilepsy (QOLIE-10-P) questionnaire, treatment compliance, and adverse events and serious adverse events.
The study will include approximately 1500 participants from multiple institutes/hospitals across Pakistan.
- Conditions
- Focal-Onset Seizures
- Being tested
- Eslicarbazepine acetate
- Keywords
- Eslicarbazepine, Eslicarbazepine acetate, APTIOM, Focal-onset seizures, Partial-onset seizures, Focal epilepsy, Carbamazepine, Oxcarbazepine, Seizure control, Quality of life, QOLIE-10-P, Real-world evidence
- Medical subject headings
- Seizures, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine acetateDrug
Eslicarbazepine acetate administered orally once daily as prescribed by the treating physician in routine clinical practice. Newly diagnosed patients will typically initiate treatment at 400 mg/day and increase to 800 mg/day after one week. Patients switching from carbamazepine or oxcarbazepine may initiate treatment at 400-600 mg/day according to clinical judgment. Dose adjustments, including increases up to 1600 mg/day when clinically indicated and tolerated, will be determined by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed / Treatment-Naïve | Adults with diagnosed focal-onset seizures who are newly diagnosed/treatment-naïve and receive eslicarbazepine as part of routine clinical care. Receives: Drug: Eslicarbazepine acetate | |
| Previously Treated With Carbamazepine/Oxcarbazepine | Adults with focal-onset seizures previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects and receive eslicarbazepine as part of routine clinical care. Receives: Drug: Eslicarbazepine acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Seizure Frequency
Measured: From Baseline to Month 3
Seizure Response Rate
Measured: From Baseline to Month 3
Secondary outcomes (2)
Change in QOLIE-10-P Score
Patient Quality of Life in Epilepsy Score has 10 questions being scored 1 to 5 each with lower score indicating poorer quality of life and higher score indicating better quality of life with total score ranging from 10 to 50. An increase in score indicates improvement in quality of life.
Measured: From Baseline to Month 3
Adverse Events and Serious Adverse Events
Measured: From Baseline through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start2 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Focal-Onset SeizuresStudies of the same condition, open and under way.
- 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
- 1,500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safia bano, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793396
- Sponsor's protocol ID
- 825/RC/KEMU
- Acronym
- ENGAGE
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
18. Gil-Nagel A, Villanueva V, Toledo M, et al. Improvement in quality of life and seizure reduction with eslicarbazepine acetate: The Spanish EPOS study. Acta Neurol Scand. 2016 Apr;133(4):237-244.
Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
PubMed 1988901316. Soares-da-Silva P, Almeida L, Falcão A, et al. Eslicarbazepine acetate: overview of the clinical pharmacokinetics and pharmacodynamics. Expert Opin Drug Metab Toxicol. 2015 Feb;11(2):1841-1852
Hufnagel A, Ben-Menachem E, Gabbai AA, Falcao A, Almeida L, Soares-da-Silva P. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res. 2013 Feb;103(2-3):262-9. doi: 10.1016/j.eplepsyres.2012.07.014. Epub 2012 Aug 4.
PubMed 22871333Elger C, Halasz P, Maia J, Almeida L, Soares-da-Silva P; BIA-2093-301 Investigators Study Group. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009 Mar;50(3):454-63. doi: 10.1111/j.1528-1167.2008.01946.x. Epub 2009 Feb 21.
PubMed 1924342413. Villanueva V, Garcés M, López-González FJ, et al. Safety, efficacy and quality of life data from a 1-year, multicenter, observational study of eslicarbazepine acetate in adults with focal seizures in clinical practice (EPOS study). Epilepsy Behav. 2014 Oct;41:1-9.
Sperling MR, Abou-Khalil B, Harvey J, Rogin JB, Biraben A, Galimberti CA, Kowacs PA, Hong SB, Cheng H, Blum D, Nunes T, Soares-da-Silva P; 304 Study Team. Eslicarbazepine acetate as adjunctive therapy in patients with uncontrolled partial-onset seizures: Results of a phase III, double-blind, randomized, placebo-controlled trial. Epilepsia. 2015 Feb;56(2):244-53. doi: 10.1111/epi.12894. Epub 2014 Dec 22.
PubMed 25528898Ben-Menachem E, Gabbai AA, Hufnagel A, Maia J, Almeida L, Soares-da-Silva P. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010 May;89(2-3):278-85. doi: 10.1016/j.eplepsyres.2010.01.014. Epub 2010 Mar 17.
PubMed 2029918910. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate: a novel once-daily antiepileptic drug for the treatment of focal seizures. Expert Opin Pharmacother. 2007;8(13):2103-2111
9. Soares-da-Silva P, Pires N, Bonifácio MJ, Loureiro AI. Pharmacokinetic interactions of eslicarbazepine acetate with antiepileptic or cardiovascular drugs. Drug Metab Drug Interact. 2012;27(3):199-209
Zaccara G, Giovannelli F, Cincotta M, Carelli A, Verrotti A. Clinical utility of eslicarbazepine: current evidence. Drug Des Devel Ther. 2015 Feb 10;9:781-9. doi: 10.2147/DDDT.S57409. eCollection 2015.
PubMed 25709402Hebeisen S, Pires N, Loureiro AI, Bonifacio MJ, Palma N, Whyment A, Spanswick D, Soares-da-Silva P. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 2015 Feb;89:122-35. doi: 10.1016/j.neuropharm.2014.09.008. Epub 2014 Sep 19.
PubMed 25242737Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093). Neurotherapeutics. 2007 Jan;4(1):88-96. doi: 10.1016/j.nurt.2006.10.005.
PubMed 171990204. Perucca E. Pharmacoresistance in epilepsy: how should it be defined? CNS Drugs. 1998;10(3):171-179
Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
PubMed 24730690
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Real-World Evidence, Multicenter Study to Evaluate the Efficacy and Safety of Eslicarbazepine in Managing Epilepsy
- ClinicalTrials.gov ID
- NCT07793396
- Acronym / sponsor ID
- ENGAGE / 825/RC/KEMU
- Conditions
- Focal-Onset Seizures
- Keywords
- Eslicarbazepine, Eslicarbazepine acetate, APTIOM, Focal-onset seizures, Partial-onset seizures, Focal epilepsy, Carbamazepine, Oxcarbazepine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Aug 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.
This prospective multicenter observational study will evaluate the effectiveness, safety, tolerability, and impact on quality of life of eslicarbazepine in adults with focal-onset seizures in routine clinical practice. Participants will include newly diagnosed patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects. Treatment with eslicarbazepine will be initiated or changed at the discretion of the treating physician in accordance with routine clinical practice. Participants will be followed for 3 months.
Detailed description
This prospective, multicenter observational study will assess the effectiveness, safety, and tolerability of eslicarbazepine in adults with focal-onset epilepsy, including newly diagnosed patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects.
Treatment decisions, including the decision to initiate eslicarbazepine or switch from another antiseizure medication, will be made by the treating physician according to routine clinical practice and the approved product information. The study will therefore observe outcomes associated with eslicarbazepine use without assigning participants to treatment.
Eslicarbazepine will be administered orally once daily. Newly diagnosed patients will typically start at 400 mg/day and increase to 800 mg/day after one week. Patients switching from carbamazepine or oxcarbazepine may start at 400-600 mg/day according to clinical judgment and may undergo an overnight switch or cross-titration. If clinically indicated and tolerated, the dose may be increased to a maximum of 1600 mg/day. Dose adjustments will be guided by tolerability, seizure control, and adverse-event monitoring.
Participants will be assessed at baseline, Day 7, and Month 3. Data collected will include demographic and clinical information, concomitant medications, seizure occurrence and frequency, quality of life using the Patient Quality of Life in Epilepsy (QOLIE-10-P) questionnaire, treatment compliance, and adverse events and serious adverse events.
The study will include approximately 1500 participants from multiple institutes/hospitals across Pakistan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed / Treatment-Naïve | – | Drug: Eslicarbazepine acetateAdults with diagnosed focal-onset seizures who are newly diagnosed/treatment-naïve and receive eslicarbazepine as part of routine clinical care. |
| Previously Treated With Carbamazepine/Oxcarbazepine | – | Drug: Eslicarbazepine acetateAdults with focal-onset seizures previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects and receive eslicarbazepine as part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of approximately 1,500 adult male and female patients with diagnosed focal-onset (partial-onset) seizures across multiple institutes/hospitals in Pakistan. Participants will include newly diagnosed, treatment-naïve patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects. Eslicarbazepine treatment will be initiated or switched at the discretion of the treating physician in accordance with routine clinical practice and applicable prescribing information.
Key inclusion criteria (3 listed)
- Adult patients (aged at least 18 years) with diagnosed partial-onset seizures.
- Newly diagnosed (treatment-naïve) or previously treated with Carbamazepine or Oxcarbazepine and inadequately controlled or intolerant.
- Patient or Legal Representative is willing and able to provide informed consent, or, in the absence of a legal representative, an Independent Healthcare Professional provides authorization for patient enrolment.
Key exclusion criteria (3 listed)
- Any hypersensitivity to Eslicarbazepine.
- Female patients who are pregnant or lactating.
- Patients who have a contraindication to the medicine or any component of prescribed therapy.
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 |
|---|---|---|
| Eslicarbazepine acetateEslicarbazepine acetate administered orally once daily as prescribed by the treating physician in routine clinical practice. Newly diagnosed patients will typically initiate treatment at 400 mg/day and increase to 800 mg/day after one week. Patients switching from carbamazepine or oxcarbazepine may initiate treatment at 400-600 mg/day according to clinical judgment. Dose adjustments, including increases up to 1600 mg/day when clinically indicated and tolerated, will be determined by the treating physician. | Drug | Newly Diagnosed / Treatment-Naïve, Previously Treated With Carbamazepine/Oxcarbazepine |
Primary outcome
Change in Seizure Frequency
Time frame: From Baseline to Month 3
Seizure Response Rate
Time frame: From Baseline to Month 3
2 secondary outcomes
Change in QOLIE-10-P Score
Time frame: From Baseline to Month 3
Adverse Events and Serious Adverse Events
Time frame: From Baseline through Month 3
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 9 Sep 2026.
- Background18. Gil-Nagel A, Villanueva V, Toledo M, et al. Improvement in quality of life and seizure reduction with eslicarbazepine acetate: The Spanish EPOS study. Acta Neurol Scand. 2016 Apr;133(4):237-244.
- Background: PubMed 19889013Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
- Background16. Soares-da-Silva P, Almeida L, Falcão A, et al. Eslicarbazepine acetate: overview of the clinical pharmacokinetics and pharmacodynamics. Expert Opin Drug Metab Toxicol. 2015 Feb;11(2):1841-1852
- Background: PubMed 22871333Hufnagel A, Ben-Menachem E, Gabbai AA, Falcao A, Almeida L, Soares-da-Silva P. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res. 2013 Feb;103(2-3):262-9. doi: 10.1016/j.eplepsyres.2012.07.014. Epub 2012 Aug 4.
- Background: PubMed 19243424Elger C, Halasz P, Maia J, Almeida L, Soares-da-Silva P; BIA-2093-301 Investigators Study Group. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009 Mar;50(3):454-63. doi: 10.1111/j.1528-1167.2008.01946.x. Epub 2009 Feb 21.
- Background13. Villanueva V, Garcés M, López-González FJ, et al. Safety, efficacy and quality of life data from a 1-year, multicenter, observational study of eslicarbazepine acetate in adults with focal seizures in clinical practice (EPOS study). Epilepsy Behav. 2014 Oct;41:1-9.
- Background: PubMed 25528898Sperling MR, Abou-Khalil B, Harvey J, Rogin JB, Biraben A, Galimberti CA, Kowacs PA, Hong SB, Cheng H, Blum D, Nunes T, Soares-da-Silva P; 304 Study Team. Eslicarbazepine acetate as adjunctive therapy in patients with uncontrolled partial-onset seizures: Results of a phase III, double-blind, randomized, placebo-controlled trial. Epilepsia. 2015 Feb;56(2):244-53. doi: 10.1111/epi.12894. Epub 2014 Dec 22.
- Background: PubMed 20299189Ben-Menachem E, Gabbai AA, Hufnagel A, Maia J, Almeida L, Soares-da-Silva P. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010 May;89(2-3):278-85. doi: 10.1016/j.eplepsyres.2010.01.014. Epub 2010 Mar 17.
- Background10. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate: a novel once-daily antiepileptic drug for the treatment of focal seizures. Expert Opin Pharmacother. 2007;8(13):2103-2111
- Background9. Soares-da-Silva P, Pires N, Bonifácio MJ, Loureiro AI. Pharmacokinetic interactions of eslicarbazepine acetate with antiepileptic or cardiovascular drugs. Drug Metab Drug Interact. 2012;27(3):199-209
- Background: PubMed 25709402Zaccara G, Giovannelli F, Cincotta M, Carelli A, Verrotti A. Clinical utility of eslicarbazepine: current evidence. Drug Des Devel Ther. 2015 Feb 10;9:781-9. doi: 10.2147/DDDT.S57409. eCollection 2015.
- Background: PubMed 25242737Hebeisen S, Pires N, Loureiro AI, Bonifacio MJ, Palma N, Whyment A, Spanswick D, Soares-da-Silva P. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 2015 Feb;89:122-35. doi: 10.1016/j.neuropharm.2014.09.008. Epub 2014 Sep 19.
- Individual participant dataSharing planned: No
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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.
Safia Assistant Professor Neurology, FCPS Neurology, PhD Scholar contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal-Onset Seizures, run by King Edward Medical University at 1 site in Pakistan.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Safia Assistant Professor Neurology, FCPS Neurology, PhD Scholar (+92-301-4154276, safiabano@kemu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Seizure Frequency (time frame: From Baseline to Month 3). The study lists 2 primary outcomes in all. 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 NCT07793396, which also lists 17 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 Sep 2026.