Anti-epileptogenic Effects of Eslicarbazepine Acetate

NCT06597084 | Completed Phase 2 Results DMC

• 2 other identifiers: BIA-2093-2132018-002747-29
• Study Type: interventional
• Target: 129
• Locations: 9 countries
• Sites: 22

Brief Summary

This study aims to assess if eslicarbazepine acetate (ESL) treatment (started within 96 hours after stroke occurrence and continued for 30 days) changes the incidence of unprovoked seizures (USs) within the first 6 months after randomisation as compared to placebo

Conditions

Post Stroke Epilepsy

Keywords

Prophylaxis; Post-stroke; Epilepsy; BIA 2-093; Unprovoked seizures; Eslicarbazepine acetate; Anti-epileptogenic; Bial - Portela & Ca, S.A.

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate)

  Deaths before the first US or patients without evaluable assessment of the primary endpoint will be counted as treatment failures. To show that ESL (Group A) is superior to placebo (Group B), the primary null hypothesis will be tested against the alternative hypothesis

  First 6 months after randomisation

Secondary Outcomes (19)

• Proportion of Patients Who Experience the First US During the First 12 Months After Randomisation

  First 12 months after randomisation

• Proportion of Patients Who Experience the First US During the Course of the Trial

  Until 18 months after randomisation

• Number of Acute Symptomatic Seizure (ASS)

  During the first 7 days after stroke

• Probability of Failure at 6, 12, and 18 Months After Randomization

  Over 18 months follow-up period

• Time to First US After Stroke Occurrence.

  Over 18 months follow-up period

Study Arms (2)

Group A

EXPERIMENTAL

ESL 800 mg

Drug: ESL 800 mg

Group B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ESL 800 mg DRUG

800 mg ESL tablets for oral administration. In case a patient is unable to swallow the whole tablet, the tablet can be crushed or divided into equal doses at the score line.

Also known as: Eslicarbazepine acetate, BIA 2-093

Group A

Placebo DRUG

Placebo tablets for oral administration, matching the test product. In case a patient is unable to swallow the whole tablet, the tablet can be crushed or divided into equal doses at the score line.

Group B

Eligibility Criteria

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

You may qualify if:

• Patients must meet ALL of the following criteria:
• Male or female patient aged 18 years or above;
• Acute intracerebral haemorrhage with a CAVE score ≥ 3 or acute ischaemic stroke with a SeLECT score ≥ 6, in each case confirmed by magnetic resonance imaging (MRI)/computed tomography (CT).
• Time of stroke occurrence is known and V1b is planned within 96 hours.
• Brain scan analysis has reliably excluded structural brain lesions that can mimic stroke, e.g. cerebral tumour or brain abscess, etc.
• a. Patient is able to give informed consent and to write and has signed written informed consent OR b. Patient is able to give informed consent, but unable to write and has provided verbal witnessed consent OR c. Patient is unable to give informed consent, but likely to regain this ability until V2, and the informed consent is deferred OR d. Patient is unable to give informed consent, but likely to regain this ability until V2, and patient's legal representative (according to the respective national/local requirements) has provided written informed consent.
• Female patients without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female patients with childbearing potential must not be pregnant as confirmed by a negative pregnancy test and sexually active females must use a medically acceptable effective nonhormonal method of contraception up to the end of the current menstrual cycle after stopping treatment. Acceptable methods for women are surgical intervention (e.g. bilateral tubal occlusion), intrauterine device, double-barrier methods, true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient) and vasectomised male partner, provided that he is the sole partner of that patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• a. Patient is able to give informed consent and to write and has signed a written informed consent OR b. Patient is able to give informed consent, but unable to write and has provided verbal witnessed consent.

You may not qualify if:

• Patients are to be excluded from the trial for ANY ONE of the following reasons:
• Contraindication to ESL, i.e. known hypersensitivity to ingredients of ESL formulation or other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine), or second or third degree atrioventricular (AV) block not corrected with a permanent pacemaker.
• Known Han Chinese or Thai ancestry.
• Sinus venous thrombosis.
• Spontaneous sub-arachnoid haemorrhage due to e.g. aneurysmatic or arteriovenous malformation.
• History of USs prior to primary stroke.
• Impaired pre-stroke level of function, i.e. modified Rankin Scale (mRS) score \> 3 prior to first stroke occurrence.
• History of AED use before primary stroke within the last 5 years as defined in the list of not allowed AEDs.
• Use of ESL, unless provided as IMP of this trial, and oxcarbazepine.
• Severe hepatic impairment.
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 (measured at V1a).
• Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis.
• History of suicidal ideation or suicide attempt within the past 3 years.
• Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the trial treatment or may jeopardise the patient's safety, compliance or adherence to protocol requirements, such as significant psychiatric, cardiovascular, respiratory, metabolic, endocrine, haematologic, infectious or neurological disease.
• For women: Pregnancy or breast-feeding.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (22)

Klinikum am Wörthersee, Abteilung fur Neurologie

Klagenfurt, FeschnigstraBe 11, 9020, Austria

Location

Medizinische Universität Innsbruck, Universitätsklinik für Neurologie

Innsbruck, Innrain 52, 6020, Austria

Location

Kepler University Hospital, Med Campus III, Department of Neurology 2

Linz, Krankenhausstraße 9, 4021, Austria

Location

Clinical Research Center Salzburg GmbH

Salzburg, Strubergasse 21, 5050, Austria

Location

Kepler University Hospital GmbH, Neuromed Campus, Department of Neurology 1

Linz, Wagner-Jauregg-Weg 15, 4020, Austria

Location

Hospices Civils de Lyon, Neurological Hospitals

Bron, Boulevard Pinel, 59, 69677, France

Location

UKGM Universitatsklinikum Marburg, Klinik und Poliklinik fur Neurologie

Marburg, Baldingerstrabe, 35043, Germany

Location

Neurologische Universitatsklinik

Tübingen, Hoppe-Seyler-Strabe 3, 72076, Germany

Location

Universitatsklinikum Essen, Klinik fur Neurologie

Essen, Hufelandstr. 55, 45147, Germany

Location

LMU Ludwig-Maximilians-Universitat, Munchen, Klinikum Grobhadern, Neurologische Klinik und Poliklinik, Experimentelle Neurologie

München, Marchioninistrabe 15, 81377, Germany

Location

Uniklinik RWTH Aachen, Klinik für Neurologie

Aachen, Pauwelsstr. 30, 52074, Germany

Location

Universitatsklinikum Erlangen, Neurologische Klinik

Erlangen, Schwabachanlage 6, 91054, Germany

Location

Sheba Medical Center, Neurology Department, Stroke Unit

Ramat Gan, Emek Ha'ella 1, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center, Neurology Division

Tel Aviv, Weizmann 6, 64239, Israel

Location

Clinica Neurologica e di Neuroriabllltazione - Azienda / Ospedallero-Universitarla S. Maria della Miserrcordia

Udine, P. Le S. Maria Della Misericordia, 15, 33100, Italy

Location

Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale Cattinara - Clinica Neurologica

Trieste, Strada Di Fiume 447, 34149, Italy

Location

Azienda Sanitaria dell'Alto Adige - Ospedale di Merano

Merano, Via Rossini 5, 39012, Italy

Location

Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital Santa Maria - Serviço de Neurologia

Lisbon, Avenida Prof. Egas Moniz, 1649-035, Portugal

Location

Hospital Universitario Fundación Jiménez Diaz

Madrid, Avda. de Los Reyes Catolicos, 2, 28040, Spain

Location

Sahlgrenska universitetssjukhuset, Neurosjukvarden

Gothenburg, Bia Straket 7, 41345, Sweden

Location

King's College Hospital

London, Denmark Hill, SE5 9RS, United Kingdom

Location

Institute of Neurology

London, Queen Square, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Responsible of Clinical Operations
• Organization: BIAL - Portela & Ca, SA

clinical.trials@bial.com

+351229866100

Study Officials

• Eugen Trinka, MD MSc FRCP

  Universitätsklinik für Neurologie

  PRINCIPAL INVESTIGATOR

• Matthias Koepp, MD PhD FRCP

  UCL Institute of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: May 29, 2019
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); IL (2); AU (5); ES (1); PT (1); GB (2); FR (1); IT (3); SE (1)