ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

NCT03082222 | Completed DMC

• 1 other identifier: E2093-M044-405
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Focal Epilepsy

Keywords

partial onset seizures with or without secondary generalization

Outcome Measures

Primary Outcomes (1)

• Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)

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

Secondary Outcomes (7)

• Change from baseline in total seizure frequency

  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)

• Change from baseline in seizure frequency by seizure type

  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)

• Responder Rate

  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 seizure free state

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

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

  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)

Study Arms (3)

Group 1

Participants with epilepsy, partial onset seizures with or without secondary generalization with one concomitant antiepileptic drug (AED) at baseline

Group 2

Participants with epilepsy, partial onset seizures with or without secondary generalization with two or more concomitant AEDs at baseline

Group 3

Participants with epilepsy, partial onset seizures with or without secondary generalization with eslicarbazepine acetate (ESL) as anticonvulsant monotherapy

Eligibility Criteria

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

Study Population

Eligible participants appearing to their treating physician or clinic for routine visits will be invited to participate in the study

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eisai GmbH: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 17, 2017
• Study Start: July 1, 2015
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: September 12, 2019

Record last verified: 2019-08

Locations

DE (1)