Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bial - Portela C S.A.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01532726
First received: February 10, 2012
Last updated: May 30, 2014
Last verified: November 2013
  Purpose

This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.


Condition Intervention
Epilepsy
Drug: ESL

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Non-Interventional, Prospective Study to Assess Seizure Control and Tolerability of Eslicarbazepine Acetate as Adjunctive Therapy to One Baseline Antiepileptic Drug, in Adults With Partial-Onset Seizures With or Without Secondary Generalization

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • ESL retention rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Proportion of patients on ESL treatment at the final assessment


Secondary Outcome Measures:
  • CGI-C score at the final assessment. [ Time Frame: 9 monthss ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Changes in CGI-S score from baseline to final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • CGI-Efficacy Index scores at the final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Proportion of patients who are responders to ESL (at least 50% reduction in seizure frequency) at the final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Proportion of seizure-free patients within the 12 weeks prior to final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Proportion of seizure-free patients within the 4 weeks prior to final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Changes in seizure frequency for partial seizures with or without secondary generalization, from baseline to final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Changes in seizure frequency for partial seizures without secondary generalization, from baseline to final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Changes in seizure frequency for partial seizures with secondary generalization, from baseline to final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Assessment of effectivenes

  • Changes in QOLIE-10-P scores from baseline to final assessment [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    assessment of Quality of life

  • Occurrence of AEs during the study (overall and treatment-related) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    assessment of Adverse Events


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eslicarbazepine Acetate (ESL)
ESL and concomitant medication should be managed by the neurologist according to the respective SPC.Summary of Product Characteristics
Drug: ESL
ESL 400/800/1200 mg tablets once daily
Other Name: Zebinix

Detailed Description:

To ensure non-interventional status, the neurologist's decision that it is in the patient's best interest to be prescribed with adjunctive ESL has to be made before and independently of his/her decision to include the patient in the study. At all circumstances during the study the patients will be treated and followed according to routine clinical practice. ESL and concomitant medication should be managed by the neurologist according to the respective Summary of Product Characteristics (SPC).In order to reflect real-life practice and to ensure the observational nature of this study, no fixed time-points for study assessment were defined. Intermediate follow-up data will be collected whenever a patient attends to the study's neurologist consultation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with Partial-Onset Seizures With or Without Secondary Generalization

Criteria

Inclusion Criteria:

  • Male or female outpatient, 18 years or older;
  • The patient has an established diagnosis of epilepsy and has experienced at least one partial-onset seizure, with or without secondary generalization, within four weeks prior to initiation of adjunctive ESL;
  • The patient is not sufficiently controlled on a current antiepileptic monotherapy and, in the neurologist clinical judgment, it is in the patient's best interest to be prescribed with adjunctive ESL;
  • The neurologist's decision to prescribe ESL has been made before and independently of his/her decision to include the patient in this study;
  • The patient's treatment is in accordance with the SPC of ESL;
  • Written informed consent from the patient (or legally acceptable representative, if the subject is unable to provide informed consent).

Exclusion Criteria:

  • Known hypersensitivity to the active substance, carboxamide derivatives (e.g. oxcarbazepine or carbamazepine) or to any of its excipients;
  • Patient with 2nd or 3rd degree atrioventricular block;
  • Patient treated with an experimental drug within four weeks prior to the introduction of ESL;
  • Female patient who is pregnant, lactating, or who is planning to become pregnant during the study period;
  • Patient starting ESL outside the approved SPC at enrolment.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532726

Contacts
Contact: Helder Fernandes, MD +351 229 866 100 helder.fernandes@bial.com
Contact: Rui Sousa, MD + rui.sousa@bial.com

Locations
Portugal
Hospital Fernando da Fonseca Recruiting
Lisboa, Portugal, 2720-276
Contact: Francisco A. Pinto, MD    214348200      
Principal Investigator: Francisco A. Pintp, MD         
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: João Chaves, MD Centro Hospitalar do Porto
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01532726     History of Changes
Other Study ID Numbers: BIA-2093-403
Study First Received: February 10, 2012
Last Updated: May 30, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Partial-Onset Seizures
Eslicarbazepine Acetate
ESL
BIA 2-093
BIAL

Additional relevant MeSH terms:
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014