Prevention of Epilepsy in Stroke Patients at High Risk of Developing Unprovoked Seizures: Anti-epileptogenic Effects of Eslicarbazepine Acetate
Phase: PHASE2
Conditions: Post Stroke Epilepsy
Sponsor: Bial - Portela C S.A.

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 1 of 11 
Bial - Portela & Ca, S.A 
 
CLINICAL TRIAL PROTOCOL  
Synopsis 
Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: 
anti-epileptogenic effects of eslicarbazepine acetate  
 
Protocol Number 
BIA-2093-213 
EudraCT Number 
2018-002747-29 
Phase 
IIa 
Version 
Final Version 2.0 
Date 
24-OCT-2018 
Product Name 
Eslicarbazepine acetate (BIA 2-093) 
Indication 
Prophylaxis of post-stroke epilepsy  
Sponsor 
Bial - Portela & Ca, S.A. 
À Av. da Siderurgia Nacional  
4745-457 Coronado (S. Romão e S. Mamede) 
Portugal 
Phone: +351 229866100 
Fax:     +351 229866192 
http://www.bial.com 
24/7 Medical Contact 
SCOPE International Medical Monitoring 
Phone: +370 52 360 336 
Central SAE Fax: +370 52 327 903 
safety@scope-international.com 
 
The information contained in this document is the property of Bial and may not be 
disclosed to parties not associated with the clinical investigation or used for any purpose 
without prior written consent of Bial. 
Throughout this document, symbols indicating proprietary names (®, ™) are not 
displayed. Hence the appearance of product names without these symbols does not imply 
that these names are not protected. 
This trial will be performed in compliance with the protocol, Good Clinical Practices 
(GCP) and applicable regulatory requirements, including the archiving of essential 
documents. 
 
 
 

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 2 of 11 
PROTOCOL SYNOPSIS 
Name of Sponsor/company: Bial - Portela & Ca, S.A., À Av. da Siderurgia Nacional, 
4745-457 Coronado (S. Romão e S. Mamede), Portugal 
Name of active ingredient: Eslicarbazepine acetate (BIA 2-093) 
Title of trial: Prevention of epilepsy in stroke patients at high risk of developing unprovoked 
seizures: anti-epileptogenic effects of eslicarbazepine acetate 
Trial number: BIA-2093-213  
EudraCT number: 2018-002747-29 
Steering Committee:  
Prof. Matthias Koepp, MD PhD FRCP, UCL Institute of Neurology, National Hospital for 
Neurology and Neurosurgery, Queen Square, London WC1N 3BG, United Kingdom  
Prim. Univ. Prof. Dr. Mag. Eugen Trinka, MD, MSc, FRCP, Universitätsklinik für 
Neurologie, Christian-Doppler-Klinik, Ignaz-Harrer-Str. 79, 5020 Salzburg, Austria 
Trial centres: Up to 22 sites in 7 European countries (Austria, France, Germany, Italy, 
Spain, Sweden and United Kingdom) and Israel. Other sites and other countries may be added 
as needed. 
Planned duration of the trial: 
 First patient first visit: 
Q1 2019 
 Last patient last visit: 
Q2 2021 
Phase of development: IIa 
Objectives: 
Primary: 
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. 
Secondary: 
1. To assess if ESL treatment (started within 96 hours after stroke occurrence and continued 
for 30 days) changes the incidence of USs within the first 12 months after randomisation 
as compared to placebo  
2. To assess if ESL treatment (started within 96 hours after stroke occurrence and continued 
for 30 days) changes the incidence of USs during the course of the trial - until 18 months 
after randomisation as compared to placebo 
3. To assess the number of acute symptomatic seizures (ASs) 
To assess the effect of ESL treatment over 18 months follow-up period on: 
4. Time to first US after randomisation 
5. Time to first US after stroke occurrence 
6. Number and 4-week rate of USs 
7. Functional outcome, assessed by Barthel Index original 10-item version (BI) 
8. Functional outcome, assessed by National Institutes of Health Stroke Scale (NIHSS) 
9. Post-stroke depression, assessed by Patient Health Questionnaire (PHQ-9) 
10. Overall survival 

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 3 of 11 
Safety: 
To assess the effect of ESL treatment on: 
11. Treatment emergent adverse events (TEAEs) incl. findings from physical and 
neurological examinations 
12. Laboratory parameters 
13. Vital signs 
14. Electrocardiogram (ECG) 
15. Suicidal ideation and behaviour, assessed by PHQ-9 (question 9) 
Exploratory:  
16. Electroencephalogram (EEG), optional 
Methods/trial design:  
The following definitions will be applied for this trial: 
Acute symptomatic seizure (AS): Epileptic seizure or status epilepticus (of any type) 
occurring within 7 days (≤ 7 days) after primary stroke. 
Unprovoked seizure (US): Epileptic seizure or status epilepticus (of any type) occurring later 
than 7 days (> 7 days) after primary stroke. 
Re-stroke: If an additional stroke occurs within the first 7 days after the primary stroke, this 
will be considered as one stroke event and will not lead to withdrawal of the patient. 
Post-stroke epilepsy: One unprovoked (or reflex) seizure with a probability of further 
seizures similar to the general recurrence risk (at least 60%) after 2 USs, occurring over the 
next 10 years. 
This is a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial in 
patients with acute intracerebral haemorrhage with a CAVE score ≥ 3 or an acute ischaemic 
stroke with a SeLECT score ≥ 6. 
At the first visit (screening/baseline, V1a), patients will undergo several examinations to 
check eligibility. The next visit (V1b) has to be performed within 96 hours after primary 
stroke occurrence. After eligibility has been confirmed, patients will be randomised 
(randomisation ratio 1:1) to treatment with ESL 800 mg (Group A) or placebo (Group B). 
Patients can receive therapies for stroke treatment according to local clinical practice at any 
time during the trial. 
Patients will start treatment with the investigational medicinal product (IMP), i.e. ESL or 
placebo, within 96 hours after primary stroke occurrence at V1b. They will continue 
treatment until Day 30 after randomisation and then be tapered off. Thereafter, patients will 
be followed up until 18 months after randomisation. Patients can concomitantly receive 
antiepileptic therapies, except commercially available ESL or oxcarbazepine, until Day 30. 
Concomitant antiepileptic therapies have to be discontinued and down-titration has to be 
started according to the respective Summary of Product Characteristics (SmPC). If the 
antiepileptic drugs (AEDs)/benzodiazepine are not already discontinued before, down-
titration must be started on Day 31 at the latest. 
If one or more AS(s) occur(s) within 7 days after primary stroke, this will not result in change 
of IMP dose. Patients having a first US will discontinue IMP treatment and will be treated at 
the discretion of the investigator until 18 months after randomisation, except with 
commercially available ESL.  
Further visits will be performed 7 days (V2, on-site), 37 days (V3, on-site), 12 weeks (V4, 
telephone), 26 weeks (V5, on-site), 38 weeks (V6, telephone), 52 weeks (V7, on-site), 
64 weeks (V8, telephone) and 78 weeks (End of Trial [EoT] visit, on-site) after V1b. Patients 

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 4 of 11 
who discontinue trial participation prematurely will be asked to come to the site for an early 
discontinuation visit (EDV). Unscheduled visits (UNS) will be performed at the discretion 
of the investigator, as necessary.  
Patients or their caregivers (as applicable) will be instructed to contact the site immediately 
after a seizure has occurred and to document seizure information in the patient diary. 
Number of patients (planned):  
Screened: 
220 
Randomised: 
200 
Indication and main criteria for inclusion and exclusion:  
Indication: Prophylaxis of post-stroke epilepsy 
Inclusion criteria: 
Patients must meet ALL of the following criteria: 
1. Male or female patient aged 18 years or above. 
2. 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).  
3. Time of stroke occurrence is known and V1b is planned within 96 hours. 
4. Brain scan analysis has reliably excluded structural brain lesions that can mimic stroke, 
e.g. cerebral tumour or brain abscess, etc. 
5. 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. 
6. 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 non-
hormonal 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. 
The requirements of the relevant ethics committees must be adhered to at all times. Written 
or verbal witnessed informed consent from the patient must be obtained until V2.  
Inclusion criteria at V1b 
7. V1b is within 96 hours after stroke occurrence. 

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 5 of 11 
Inclusion criteria at V2 (only applicable for patients who were unable to give informed 
consent at V1a.) 
8. 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. 
Exclusion criteria:  
(as per patient interview, medical records or reported by family members) 
Patients are to be excluded from the trial for ANY ONE of the following reasons: 
1. 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. 
2. Known Han Chinese or Thai ancestry. 
3. History of previous stroke (other than the one described in inclusion criteria no. 2 - 3). 
4. Sinus venous thrombosis. 
5. Spontaneous sub-arachnoid haemorrhage due to e.g. aneurysmatic or arteriovenous 
malformation. 
6. History of USs prior to primary stroke. 
7. Impaired pre-stroke level of function, i.e. modified Rankin Scale (mRS) score > 3 prior 
to first stroke occurrence. 
8. History of AED use before primary stroke within the last 5 years as defined in the list of 
not allowed AEDs. 
9. Use of ESL, unless provided as IMP of this trial, and oxcarbazepine. 
10. Severe hepatic impairment. 
11. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1a). 
12. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis. 
13. History of suicidal ideation or suicide attempt within the past 3 years. 
14. 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. 
15. For women: Pregnancy or breast-feeding.  
16. Previous enrolment in this trial or participation in any other investigational drug trial 
within the past 30 days (or 5 half-lives of IMP whichever is longer) prior to V1a. 
17. Persons committed to an institution by virtue of an order issued either by the judicial or 
other authorities. 
18. Employees of the investigator or trial centre, with direct involvement in the proposed 
trial or other studies under the direction of that investigator or trial centre, as well as 
family members of the employees or the investigator. 
Duration of treatment for the individual patient: Patients will receive IMP for 30 days. 
Afterwards, they will be tapered-off for 7 days before stopping the intake.  

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 6 of 11 
Test product, dose and mode of administration (Group A): 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.  
Placebo, dose and mode of administration (Group B): 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. 
IMP dosing schedule: IMP treatment will start at V1b (i.e. within 96 hours after primary 
stroke) and will be continued for 30 days. Thereafter, the IMP will be tapered off. The dosing 
will be as follows: Patients with an eGFR > 60 mL/min/1.73 m² will receive one tablet once 
daily, i.e. 800 mg ESL or placebo. Patients with moderate renal impairment at V1a, defined 
as eGFR 30 - 60 mL/min/1.73 m², will receive half a tablet once daily, i.e. 400 mg ESL or 
placebo. As soon as eGFR has improved to > 60 mL/min/1.73 m², the dose will be increased 
to one tablet once daily (800 mg ESL or placebo). Patients developing moderate renal 
impairment during IMP intake should be adjusted to 400 mg, if applicable. 
If one or more AS(s) occur(s) within 7 days after primary stroke, this will not result in change 
of IMP dose.In case a patient has an US, IMP has to be discontinued and the patient will be 
treated at the discretion of the investigator, except with commercially available ESL. 
Criteria for evaluation:  
Primary efficacy endpoint: 
Proportion of patients who experience the first 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. 
Secondary efficacy endpoints: 
1. Proportion of patients who experience the first US during the first 12 months after 
randomisation (12 months failure rate) 
2. Proportion of patients who experience the first US during the course of the trial – until 
18 months after randomisation (18 months failure rate) 
3. Number of ASs 
4. Time to first US after randomisation 
5. Time to first US after stroke occurrence 
6. Number and 4-week rate of US 
7. BI 
8. NIHSS 
9. PHQ-9 
10. Overall survival 
Safety endpoints: 
11. TEAEs incl. findings from physical and neurological examinations 
12. Laboratory parameters (haematology, biochemistry, including eGFR and coagulation, 
and urinalysis) 
13. Vital signs 
14. ECG 
15. Suicidal ideation and behaviour (as per PHQ-9, question 9) 

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 7 of 11 
Exploratory endpoint: 
16. EEG, optional 
Statistical methods: 
Analysis sets: 
• Enrolled set (ES): All patients enrolled into this trial. 
• Safety set (SS): All patients who were randomised and were treated with at least one dose 
of IMP (ESL or placebo). Patients will be assigned to treatment groups as treated. 
• Full analysis set (FAS): All patients who were randomised and were treated with at least 
one dose of IMP (ESL or placebo). Patients will be assigned to treatment groups as 
randomised. 
• Per protocol set (PPS): All patients of the FAS without major protocol deviations. 
Patients will be assigned to treatment groups as treated. 
• EEG analysis subset: All patients in the FAS with a baseline and a post-baseline EEG 
recording available. 
The primary hypotheses will be assessed in the FAS by means of a chi-square test with 
continuity correction on the significance level of 5% (two-sided). 
Secondary efficacy analysis includes an analysis of the proportion of patients who experience 
the first US within the first 12 and within 18 months after randomisation (12 months and 18 
months failure rate, respectively), time to first US after randomisation as well as time to first 
US after stroke by means of Kaplan-Meier estimate, and cause-specific cumulative incidence 
curves to evaluate the competing risk in case of deaths before the first US, as well as 
descriptive statistics for number of ASs, number and 4-week rate of USs, the BI, the NIHSS 
score, the PHQ-9. 
EEG parameters will be evaluated exploratively using descriptive statistics. 
Safety analysis will focus on the presentation of TEAEs by system organ class (SOC) and 
preferred term (PT), and the analysis of vital signs, safety laboratory data, ECG, physical and 
neurological examination, and suicidal behaviours assessed using PHQ-9. 
Sample size estimation: Based on historical data, 26% of patients are expected to experience 
the first US within the first 6 months after stroke (i.e. failure rate) with standard of care. As 
this is a pilot trial, no empirical estimate of the treatment effect in patients randomised to 
ESL is available. For the purpose of sample size estimation, the trial is planned to have at 
least 80% power to demonstrate a significantly lower failure rate under ESL (Group A) 
compared to placebo (Group B) under the following assumptions:  
• An expected failure rate (including death before the first US) of 26% under placebo 
within the first 6 months after stroke. 
• An expected failure rate (including death before the first US) of 8% under ESL within 
the first 6 months after stroke. 
• In order to account for a missing data rate of 5% for reasons other than death before the 
first US, in each treatment arm, the sample size calculated on adjusted failure rates 
(including missing data) of 29.7% under placebo and 12.6% under ESL, respectively.  
Under these assumptions 100 randomised patients per treatment arm will ensure a power of 
the trial of at least 80% to demonstrate a significantly lower failure rate under ESL compared 

Clinical Trial Protocol BIA-2093-213, Synopsis 
Bial - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
CONFIDENTIAL  
Page 8 of 11 
to placebo by means of a two-sided chi-square test with continuity correction on a 5%-level 
of significance. 
Assuming that the failure rate in missing observations equals the failure rate with placebo for 
both treatment groups, the power of the trial is 87%. Based on the expected failure rates 
without adjustment for missing data, the power of the trial is 89%. 

Clinical Trial Protocol BIA-2093-213, Synopsis 
 
BIAL - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
 
CONFIDENTIAL  
 
Page 9 of 11 
Schedule of trial procedures 
Visits 
V1a2 
V1b2 
V215 
V315 
V4 
V5 
V6 
V7 
V8 
EoT12 
EDV3 
UNS1 
Days / Weeks after V1b 
 
 
+7 
days  
+37 
days  
+12 
weeks  
+26 
weeks  
+38 
weeks 
+52 
weeks  
+ 64 
weeks 
+ 78 
weeks 
 
 
On-site visit ⊗/telephone contact  
⊗ 
⊗ 
⊗ 
⊗ 
 
⊗ 
 
⊗ 
 
⊗ 
⊗ 
⊗/ 
Day 
-3 to -1 
1 (within 
96 h after 
stroke) 
8±2 
38+4 
85±10 
183±10 267±10 365±10 449±10 547±10 
 
 
Initiation procedures 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
9 
 
10 
 
 
 
 
 
 
 
 
()14 
Demographics 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
 
 
10 
 
 
 
 
 
 
 
 
()14 
Prior medication 
 
 
10 
 
 
 
 
 
 
 
 
()14 
Concomitant medication 
 
 
 
 
 
 
 
 
 
 
 
 
SeLECT score/CAVE score11 
4 
 
 
 
 
 
 
 
 
 
 
 
Modified Rankin Scale (mRS) 
4 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
 
 
10 
 
 
 
 
 
 
 
 
 
Randomisation (1:1)  
 
 
 
 
 
 
 
 
 
 
 
 
Medication 
 
 
 
 
 
 
 
 
 
 
 
 
First investigational medicinal product (IMP) 
administration 
 
 
 
 
 
 
 
 
 
 
 
 
Dispense IMP 
 
 
 
 
 
 
 
 
 
 
 
() 
IMP accountability 
 
 
 
 
 
 
 
 
 
 
13 
() 
Efficacy 
 
 
 
 
 
 
 
 
 
 
 
 
Issue diary (seizures)  
 
 
 
 
 
 
 
 
 
 
 
() 
Review and collect diary 
 
8 
 
 
 
 
 
 
 
 
 
() 
Seizure screening questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
Record seizures (diary/questionnaire)16 
 
 
 
 
 
 
 
 
 
 
 
 
Barthel Index (BI) 
 
 
 
 
 
 
 
 
 
 
 
() 
National Institutes of Health Stroke Scale (NIHSS) 
4 
 
 
 
 
 
 
 
 
 
 
() 
Patient Health Questionnaire (PHQ-9) 
 
 
 
 
 
 
 
 
 
 
 
() 
Electroencephalogram (EEG, optional)5 
(4) 
 
 
 
 
 
 
 
 
() 
 
() 

Clinical Trial Protocol BIA-2093-213, Synopsis 
 
BIAL - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
 
CONFIDENTIAL  
 
Page 10 of 11 
Visits 
V1a2 
V1b2 
V215 
V315 
V4 
V5 
V6 
V7 
V8 
EoT12 
EDV3 
UNS1 
Days / Weeks after V1b 
 
 
+7 
days  
+37 
days  
+12 
weeks  
+26 
weeks  
+38 
weeks 
+52 
weeks  
+ 64 
weeks 
+ 78 
weeks 
 
 
On-site visit ⊗/telephone contact  
⊗ 
⊗ 
⊗ 
⊗ 
 
⊗ 
 
⊗ 
 
⊗ 
⊗ 
⊗/ 
Day 
-3 to -1 
1 (within 
96 h after 
stroke) 
8±2 
38+4 
85±10 
183±10 267±10 365±10 449±10 547±10 
 
 
Safety 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse events (AEs) 
 
 
 
 
 
 
 
 
 
 
 
 
Vital signs  
(blood pressure, heart rate, tympanic body temperature)  
 
 
 
 
 
 
 
 
 
 
 
() 
Blood withdrawal (haematology and biochemistry)6 
 
 
 
 
 
 
 
 
 
 
13 
() 
Urinalysis 
 
 
 
 
 
 
 
 
 
 
13 
() 
12-lead electrocardiogram (ECG) 
4 
 
 
 
 
 
 
 
 
 
13 
() 
Physical and neurological examination 
 
 
 
 
 
 
 
 
 
 
 
() 
Serum pregnancy test7 
 
 
 
 
 
 
 
 
 
 
 
 
Urine pregnancy test 7 
 
 
 
 
 
 
 
 
 
 
13 
() 
1. 
Unscheduled visits (UNSs) will be performed at the discretion of the investigator. Assessments in brackets are optional and can be performed at the 
discretion of the investigator. 
2. 
If all conditions for V1a and V1b are fulfilled, V1a and V1b can be performed on the same day. 
3. 
An early discontinuation visit (EDV) should be performed within 10 days, if possible, on withdrawal. 
4. 
If examination was done after primary stroke, the results should be used and the examination does not need to be repeated at V1a. 
5. 
EEGs are optional assessments and will be performed at the discretion of the investigator. 
6. 
Including eGFR and coagulation. At V1a also thyroid function.  
7. 
Only in women of childbearing potential. Frequency may be adapted to meet specific country-specific/local requirements. 
8. 
The diary will only be reviewed but not be collected at V1b. 
9. 
If a patient is unable to give written or verbal consent at V1a, patient consent can be deferred or the patient’s legal representative must provide written 
informed consent (according to country specific requirements). Written or verbal witnessed informed consent from the patient must be obtained until 
V2. 
10. Only applicable for patients who were unable to give informed consent at V1a. 
11. The scores for “Severity of stroke, Large-artery atherosclerotic aetiology, Early seizures, Cortical involvement, Territory of middle cerebral artery” 
(SeLECT score) in patients with an acute ischaemic stroke and for “Cortical involvement, Age < 65 years, Volume of intracerebral haemorrhage 
> 10 mL and Early seizure within 7 days after intracerebral haemorrhage” (CAVE score) in patients with acute intracerebral haemorrhage. 

Clinical Trial Protocol BIA-2093-213, Synopsis 
 
BIAL - Portela & Ca, S.A. 
Final Version 2.0, 24-OCT-2018 
 
CONFIDENTIAL  
 
Page 11 of 11 
12. EoT: End of Trial visit 
13. Only applicable, if EDV is performed before V3. 
14. Only applicable if performed prior to V2 and only for patients who were unable to give informed consent at V1a. 
15. The patients will be reminded via phone call on the working day before Day 30 to either take the last tablet on Day 30 (those with ESL 400 mg) or to 
take half a tablet from Day 31 to Day 37 (those with ESL 800 mg) and (if applicable) to start the down-titration of AED/benzodiazepines according to 
the respective SmPC on Day 31, if not already discontinued before. 
16. Seizure records based on diary entries may be applicable in case of on-site visits, only.