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Completed

NCT Number: NCT03082222

ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

This is a non interventional prospective study. Centers will enroll adult participants with partial onset seizures with or without secondary generalisation for whom the clinician has decided to initiate eslicarbazepine acetate (ESL) as an adjunctive therapy or monotherapy prior to the decision to take part in this study. Participants to be enrolled into the study will receive ESL either as an adjunctive therapy to one baseline antiepileptic drug (AED) or to at least two baseline AEDs or as monotherapy. Participants will be seen at baseline and at a follow-up visit after approximately 6 months to assess retention, efficacy, tolerability, quality of life (optional), and cognitive performances (optional).

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Partial onset seizures with or without secondary generalisation in conjunction with a diagnosed epilepsy of symptomatic or unknown course.
  • The decision to prescribe Eslicarbazepine acetate (ESL) was taken independent of and prior to enrollment into this study.
  • Treatment with ESL is in agreement with the valid summary of product characteristics (SmPC) version, particularly with the licensed indication.
  • Age 18 years and older.
  • Participant's written consent.

Exclusion criteria

  • Known psychogenic non-epileptic attacks.
  • Participation in an interventional study.
  • Previous enrollment in the current study.

Treatment and study plan

Primary outcomes

  1. Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)

    Time frame: At follow-up visit (occurring after approximately 6 months of treatment)

Secondary outcomes

  1. Change from baseline in total seizure frequency

    Time frame: Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)

  2. Change from baseline in seizure frequency by seizure type

    Time frame: Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)

  3. Responder Rate

    Time frame: Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)

    Percentage of participants achieving a reduction in total seizure frequency by at least 50% within the 3-month period prior to Follow-Up in comparison with Baseline (the 3-month period prior to initiation of treatment with ESL)

  4. Percentage of participants achieving seizure free state

    Time frame: 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)

  5. Change from baseline in Quality of Life in Epilepsy Inventory-10 (QOLIE-10)

    Time frame: Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)

    Only in centers where this questionnaire is part of the clinical routine.

  6. Change from baseline in NeuroCog FX subset scores

    Time frame: Baseline (the 3 months period prior to initiation of treatment with ESL) and at follow-up visit (occurring after approximately 6 months of treatment)

  7. Percentage of participants with Adverse Events (AEs)

    Time frame: From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment)

Sponsors and collaborators

Lead sponsor

Eisai GmbH

Industry

Registry information

Official study title

An Open, Multicentric, Non-Interventional Observational Study Investigating Retention, Seizure Control and Tolerability in Epilepsy Patients With Partial Onset Seizures Receiving Eslicarbazepine Acetate (ESL) in Different Therapy Situations

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 17, 2017
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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