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ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

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ClinicalTrials.gov Identifier: NCT03082222
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai GmbH )

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).

Condition or disease
Focal Epilepsy

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Study Type : Observational
Actual Enrollment : 246 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018


Group/Cohort
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



Primary Outcome Measures :
  1. Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL) [ Time Frame: At follow-up visit (occurring after approximately 6 months of treatment) ]

Secondary Outcome Measures :
  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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082222


Locations
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Germany
Multiple Locations, Germany
Sponsors and Collaborators
Eisai GmbH
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Responsible Party: Eisai GmbH
ClinicalTrials.gov Identifier: NCT03082222    
Other Study ID Numbers: E2093-M044-405
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: August 2019
Keywords provided by Eisai Inc. ( Eisai GmbH ):
partial onset seizures with or without secondary generalization
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases