MedTrace Logo

Anti-epileptogenic Effects of Eslicarbazepine Acetate

NCT06597084 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-05-02

Study results available
· View outcomes & findings →

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

Interventions

DRUG

ESL 800 mg

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Eugen Trinka, MD MSc FRCP · Universitätsklinik für Neurologie

  • Matthias Koepp, MD PhD FRCP · UCL Institute of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2023-09-11
Completion
2023-09-11

Countries

  • Austria
  • France
  • Germany
  • Israel
  • Italy
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597084 on ClinicalTrials.gov