Trial · NCT06597084
Anti-epileptogenic Effects of Eslicarbazepine Acetate
NCT06597084, Phase 2, Completed, Bial - Portela C S.A.; results first posted 2025-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anti-epileptogenic Effects of Eslicarbazepine Acetate. Trials, record NCT06597084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06597084
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-epileptogenic Effects of Eslicarbazepine Acetate
- NCT number
- NCT06597084
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Bial - Portela C S.A.
- Conditions
- Post Stroke Epilepsy
- Interventions
- ESL 800 mg, Placebo
- First posted
- 2024-09-19
- Last updated
- 2025-05-02
- Other registries' IDs
- eudract:2018-002747-29
- Results first posted
- 2025-05-02
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | First 6 months after randomisation | 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 |
| Secondary | Proportion of Patients Who Experience the First US During the First 12 Months After Randomisation | First 12 months after randomisation | 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 |
| Secondary | Proportion of Patients Who Experience the First US During the Course of the Trial | Until 18 months after randomisation | 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 |
| Secondary | Number of Acute Symptomatic Seizure (ASS) | During the first 7 days after stroke | Number of ASSs will be summarised by means of descriptive statistics |
| Secondary | Probability of Failure at 6, 12, and 18 Months After Randomization | Over 18 months follow-up period | The time to first US after randomisation will be analysed and presented by means of the Kaplan-Meier estimate after 6, 12 and 18 months for the failure time. The time to first US will be analysed from the day of randomisation. |
| Secondary | Time to First US After Stroke Occurrence. | Over 18 months follow-up period | Analysis of time to first US will be performed using the day of stroke (before randomisation) as Day 1. The secondary objective and endpoint "Time to first US after stroke occurrence" was decided to be deleted as it is closely related to the forth secondary endpoint "Time to first US after randomisation" and therefore would not really have any additional value. |
| Secondary | Number and 4-week Rate of USs (4-week Rate of USs Was Omitted With SAP, Final Version 1.0, 22 NOV 2023). | Over 18 months follow-up period | The total number and rate of USs, standardised per 4 weeks, in all patients and in patients with US(s) only will be summarised by means of descriptive statistics. The secondary objective and endpoint "4-week rate of USs" was decided to be deleted as this information will not be meaningful for this trial. |
| Secondary | Barthel Index (BI) Original 10-item Version | Barthel Index data is collected at Baseline, V3 (+37 days), V5 (+26 weeks), V7 (+52 weeks), End of trial visit (EOT, +78 weeks) or Early discontinuation visit (EDV, on average 30 days), and Endpoint (18 months). | The Barthel Index at baseline and post-baseline visits of each patient will be calculated adding the individual scores from each item. Baseline is the value assessed before first IMP intake. Endpoint is the last non-missing value collected after the first IMP intake. The BI is a widely used score to measure the performance in activities of daily living of patients with stroke and other neuromuscular or musculoskeletal disorders in the following 10 categories: 1. Feeding (scored as 0, 5, 10) 2. Moving from a wheelchair to a bed and back again (scored as 0, 5, 10, 15) 3. Personal hygiene (scored as 0, 5) 4. Getting on and off the toilet (scored as 0, 5, 10) 5. Self-bathing (scored as 0, 5) 6. Walking on a level surface (scored as 0, 5, 10, 15) 7. Ascending and descending stairs (scored as 0, 5, 10) 8. Dressing (scored as 0, 5, 10) 9. Controlling bowels (scored as 0, 5, 10) 10. Controlling bladder (scored as 0, 5, 10) The minimum value means with help and maximum independent |
| Secondary | National Institutes of Health Stroke Scale (NIHSS) | National Institutes of Health Stroke Scale (NIHSS) data is collected at Baseline, V3 (+37 days), V5 (+26 weeks), V7 (+52 weeks), End of trial visit (EOT, +78 weeks) or Early discontinuation visit (EDV, on average 30 days), and Endpoint (18 months). | The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficits. The following questions will be asked: 1a. Level of Consciousness (LOC) (scored as 0, 1, 2, 3) 1b. LOC Questions (scored as 0, 1, 2) 1c. LOC Commands (scored as 0, 1, 2) 2. Best Gaze (scored as 0, 1, 2) 3. Visual (scored as 0, 1, 2, 3) 4. Facial Palsy (scored as 0, 1, 2, 3) 5a. Motor Arm (Left Arm) (scored as 0, 1, 2, 3, 4) 5b. Motor Arm (Right Arm) (scored as 0, 1, 2, 3, 4) 6a. Motor Leg (Left Leg) (scored as 0, 1, 2, 3, 4) 6b. Motor Right (Right Leg) (scored as 0, 1, 2, 3, 4) 7. Limb Ataxia (scored as 0, 1, 2) 8. Sensory (scored as 0, 1, 2) 9. Best Language (scored as 0, 1, 2, 3) 10. Dysarthria (scored as 0, 1, 2) 11. Extinction and Inattention (formerly Neglect) (scored as 0, 1, 2) The sum of all 15 individual scores will provide the patient's total NIHSS score where 0 is "no stroke symptoms" and 42 is "severe stroke". |
| Secondary | Patient Health Questionnaire (PHQ-9) | Over 18 months follow-up period | The PHQ-9 can be used for screening, diagnosing and measuring the severity of depression in stroke patients. The patient will rate on a scale from 0 (not at all) to 3 (nearly every day) how often each of the 9 symptoms occurred during the past 2 weeks. The individual scores from each item of the PHQ-9 will be added to calculate the total PHQ-9 score for each time of examination. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | First 6 months after randomisation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients Who Experience the First US During the First 12 Months After Randomisation | First 12 months after randomisation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients Who Experience the First US During the Course of the Trial | Until 18 months after randomisation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Acute Symptomatic Seizure (ASS) | During the first 7 days after stroke | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Probability of Failure at 6, 12, and 18 Months After Randomization | Over 18 months follow-up period | The time is related to 6, 12 and 18 months and the percentage means the estimated probability to experience a first US in that specific time. | Percentage of failure | NUMBER |
| SECONDARY | Time to First US After Stroke Occurrence. | Over 18 months follow-up period | Omitted with statistical analysis plan (SAP), Final version 1.0, 22-11-2023. Secondary objective and endpoint Time to first US after stroke occurrence was decided to be deleted as it is closely related to the forth secondary endpoint Time to first US after randomisation and therefore would not really have any additional value. | ||
| SECONDARY | Number and 4-week Rate of USs (4-week Rate of USs Was Omitted With SAP, Final Version 1.0, 22 NOV 2023). | Over 18 months follow-up period | Omitted with statistical analysis plan \[SAP\], Final version 1.0, 22-NOV-2023. Secondary objective and endpoint Time to first US after stroke occurrence was decided to be deleted as it is closely related to the forth secondary endpoint Time to first US after randomisation and therefore would not really have any additional value. | ||
| SECONDARY | Barthel Index (BI) Original 10-item Version | Barthel Index data is collected at Baseline, V3 (+37 days), V5 (+26 weeks), V7 (+52 weeks), End of trial visit (EOT, +78 weeks) or Early discontinuation visit (EDV, on average 30 days), and Endpoint (18 months). | The total BI score (possible range 0 - 100) will be calculated as the sum of the individual scores from each item.~General ranges of BI describe patients' disability as follows:~80-100 - patient should be able to live independently 60-79 - minimally dependent 40-59 - partially dependent 20-39 - very dependent \<20 - total dependence | Score on a scale | MEAN |
| SECONDARY | National Institutes of Health Stroke Scale (NIHSS) | National Institutes of Health Stroke Scale (NIHSS) data is collected at Baseline, V3 (+37 days), V5 (+26 weeks), V7 (+52 weeks), End of trial visit (EOT, +78 weeks) or Early discontinuation visit (EDV, on average 30 days), and Endpoint (18 months). | Stroke severity will be stratified based on NIHSS total score as follows:~\<11 - mild and moderately severe~≥11 - severe~For each patient, the total NIHSS score at baseline and each post-baseline visit will be calculated adding the individual scores from each item. | Score on a scale | MEAN |
| SECONDARY | Patient Health Questionnaire (PHQ-9) | Over 18 months follow-up period | Points | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group A | Failures - Unprovoked seizure | 2 | Participants | |
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group B | Failures - Unprovoked seizure | 7 | Participants | |
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group A | Failures - Death | 3 | Participants | |
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group B | Failures - Death | 0 | Participants | |
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group A | Failures - Withdrawn | 12 | Participants | |
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group B | Failures - Withdrawn | 16 | Participants | |
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group A | Non-failures | 44 | Participants | |
| Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) | Group B | Non-failures | 39 | Participants | |
| Proportion of Patients Who Experience the First US During the First 12 Months After Randomisation | Group A | Failures - Unprovoked seizure | 3 | Participants | |
| Proportion of Patients Who Experience the First US During the First 12 Months After Randomisation | Group B | Failures - Unprovoked seizure | 8 | Participants |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 62 | |
| Overall Study | STARTED | Group B | 63 | |
| Overall Study | Safety Set | Group A | 61 | |
| Overall Study | Safety Set | Group B | 62 | |
| Overall Study | Full Analysis Set | Group A | 61 | |
| Overall Study | Full Analysis Set | Group B | 62 | |
| Overall Study | Electroencephalogram (EEG) Analysis Subset | Group A | 31 | |
| Overall Study | Electroencephalogram (EEG) Analysis Subset | Group B | 34 | |
| Overall Study | COMPLETED | Group A | 43 | |
| Overall Study | COMPLETED | Group B | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events424
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Group A | 4 | 61 | |
| other | Headache | Nervous system disorders | Group B | 8 | 62 | |
| other | Dizziness | Nervous system disorders | Group A | 4 | 61 | |
| other | Dizziness | Nervous system disorders | Group B | 0 | 62 | |
| other | Disturbance in attention | Nervous system disorders | Group A | 2 | 61 | |
| other | Disturbance in attention | Nervous system disorders | Group B | 1 | 62 | |
| other | Neuralgia | Nervous system disorders | Group A | 0 | 61 | |
| other | Neuralgia | Nervous system disorders | Group B | 3 | 62 | |
| other | Paraesthesia | Nervous system disorders | Group A | 2 | 61 | |
| other | Paraesthesia | Nervous system disorders | Group B | 1 | 62 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 6 | 61 |
| Total, all-cause mortality | Group B | 0 | 62 |
| Total, other adverse events | Group A | 50 | 61 |
| Total, other adverse events | Group B | 48 | 62 |
| Total, serious adverse events | Group A | 12 | 61 |
| Total, serious adverse events | Group B | 13 | 62 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A vs Group B: deaths from any cause | Trial comparisons |
| Group A vs Group B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06597084
GET https://conductscience.org/api/trials/v1/NCT06597084/results?page=2