Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)
This study is currently recruiting participants.
Verified March 2013 by Bial - Portela C S.A.
Sponsor:
Bial - Portela C S.A.
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01532726
First received: February 10, 2012
Last updated: March 25, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
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: | February 2014 |
| Estimated Primary Completion Date: | September 2013 (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
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 Prof. Doutor Fernando Fonseca, EPE | Recruiting |
| Amadora Amadora, Lisboa, Portugal, 2720-276 | |
| Contact: Francisco A. Pinto, MD 21 434 82 00 | |
| Principal Investigator: Francisco A. Pinto, 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: | March 25, 2013 |
| 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:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013