Clinical trial NCT03082222: ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Epilepsy
Keywords: partial onset seizures with or without secondary generalization
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-17
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)
timeFrame: At follow-up visit (occurring after approximately 6 months of treatment)
Secondary outcomes:
measure: Change from baseline in total seizure frequency
timeFrame: 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)
measure: Change from baseline in seizure frequency by seizure type
timeFrame: 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)
measure: Responder Rate
timeFrame: 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)
measure: Percentage of participants achieving seizure free state
timeFrame: 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)
measure: Change from baseline in Quality of Life in Epilepsy Inventory-10 (QOLIE-10)
timeFrame: 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)
measure: Change from baseline in NeuroCog FX subset scores
timeFrame: Baseline (the 3 months period prior to initiation of treatment with ESL) and at follow-up visit (occurring after approximately 6 months of treatment)
measure: Percentage of participants with Adverse Events (AEs)
timeFrame: From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment)
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
References: