Prospective Study of Eslicarbazepine in Adults With Focal-Onset Seizures

NCT07793396 | Recruiting DMC

• 1 other identifier: 825/RC/KEMU
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Focal-Onset Seizures

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

Outcome Measures

Primary Outcomes (2)

• Change in Seizure Frequency

  From Baseline to Month 3

• Seizure Response Rate

  From Baseline to Month 3

Secondary Outcomes (2)

• Change in QOLIE-10-P Score

  From Baseline to Month 3

• Adverse Events and Serious Adverse Events

  From Baseline through Month 3

Study Arms (2)

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.

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.

Drug: Eslicarbazepine acetate

Interventions

Eslicarbazepine acetate DRUG

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.

Newly Diagnosed / Treatment-Naïve; Previously Treated With Carbamazepine/Oxcarbazepine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (17)

• 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.

  BACKGROUND

• 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.

  PMID: 19889013 BACKGROUND

• 16. 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

• 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.

  PMID: 22871333 BACKGROUND

• Elger 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.

  PMID: 19243424 BACKGROUND

• 13. 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

• 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.

  PMID: 25528898 BACKGROUND

• Ben-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.

  PMID: 20299189 BACKGROUND

• 10. 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25709402 BACKGROUND

• Hebeisen 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.

  PMID: 25242737 BACKGROUND

• Almeida 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.

  PMID: 17199020 BACKGROUND

• 4. Perucca E. Pharmacoresistance in epilepsy: how should it be defined? CNS Drugs. 1998;10(3):171-179

  BACKGROUND

• 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.

  PMID: 24730690 BACKGROUND

• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

  PMID: 10660394 BACKGROUND

• 1. World Health Organization. Epilepsy. Available from: https://www.who.int/news-room/fact-sheets/detail/epilepsy

  BACKGROUND

MeSH Terms

Conditions

Seizures; Epilepsies, Partial

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Safia Assistant Professor Neurology, FCPS Neurology, PhD Scholar

CONTACT

+92-301-4154276; safiabano@kemu.edu.pk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Safia Bano (Assistant Professor Neurology)

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)