ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

Focal Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082222
• Other study ID #: E2093-M044-405
• Status: Completed
• Start date: July 2015
• Est. completion date: October 29, 2018

Study information

• Verified date: August 2019
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)		At follow-up visit (occurring after approximately 6 months of treatment)
Secondary	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)
Secondary	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)
Secondary	Responder Rate	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)	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)
Secondary	Percentage of participants achieving seizure free state		3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)
Secondary	Change from baseline in Quality of Life in Epilepsy Inventory-10 (QOLIE-10)	Only in centers where this questionnaire is part of the clinical routine.	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)
Secondary	Change from baseline in NeuroCog FX subset scores		Baseline (the 3 months period prior to initiation of treatment with ESL) and at follow-up visit (occurring after approximately 6 months of treatment)
Secondary	Percentage of participants with Adverse Events (AEs)		From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment)