Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00957684
First received: August 10, 2009
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: March 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Refractory Partial Epilepsy
Interventions: Drug: eslicarbazepine acetate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study initiation date: 15/July/2004(first visit of the first patient) Study Part I completion date: 09/November/2005(last Part I visit of the last patient) Study Part II initiation date: 11 JAN 2005 (first Part II visit of the first patient) Study Part II completion date: 04 JAN 2007 (last Part II visit of the last patient)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

After completing the baseline period, patients were randomised in a 1:1:1:1 ratio to 1 of the 3 Eslicarbazepine acetate (ESL) dose levels or to placebo.

Part II was a 1-year open-label extension for patients who had completed Part I


Reporting Groups
  Description
ESL 1200 mg Once Daily eslicarbazepine acetate : once-daily oral tablet
ESL 800 mg Once Daily eslicarbazepine acetate : once-daily oral tablet
ESL 400 mg Once Daily eslicarbazepine acetate : once-daily oral tablet
Placebo placebo : once daily placebo comparator
ESL - Part II During Part II of the study all patients received ESL, including those who had been treated with placebo during Part I. The duration of treatment during Part II was one year for all patients completing the study.

Participant Flow for 2 periods

Period 1:   PART I
    ESL 1200 mg Once Daily     ESL 800 mg Once Daily     ESL 400 mg Once Daily     Placebo     ESL - Part II  
STARTED     102     98     100     102     0  
Randomised (Safety Population)     102     98     100     102     0  
Intention-to-treat (ITT) Population     98     98     99     102     0  
Per-protocol (PP)Population     72     86     94     91     0  
COMPLETED     71     85     90     84     0  
NOT COMPLETED     31     13     10     18     0  

Period 2:   PART II
    ESL 1200 mg Once Daily     ESL 800 mg Once Daily     ESL 400 mg Once Daily     Placebo     ESL - Part II  
STARTED     0     0     0     0     314  
Patients Entered Part II     0     0     0     0     314  
COMPLETED     0     0     0     0     239  
NOT COMPLETED     0     0     0     0     75  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ESL 1200 mg 400-mg + 800-mg; once daily administration by oral route
ESL 800 mg 800-mg; once daily administration by oral route
ESL 400 mg 400-mg; once daily administration by oral route
Placebo Placebo tablets; once daily administration by oral route
Total Total of all reporting groups

Baseline Measures
    ESL 1200 mg     ESL 800 mg     ESL 400 mg     Placebo     Total  
Number of Participants  
[units: participants]
  102     98     100     102     402  
Age, Customized  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 70 years     102     96     99     102     399  
>70 years     0     2     1     0     3  
Gender  
[units: participants]
         
Female     57     44     49     54     204  
Male     45     54     51     48     198  



  Outcome Measures

1.  Primary:   Part I: Seizure Frequency   [ Time Frame: 12-week maintenance period ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Head of Clinical Research Section
Organization: BIAL - Portela & Ca, SA
phone: 351 22 986 6100
e-mail: clinical.trials@bial.com


No publications provided


Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00957684     History of Changes
Other Study ID Numbers: BIA-2093-301
Study First Received: August 10, 2009
Results First Received: March 26, 2013
Last Updated: August 2, 2013
Health Authority: Portugal: National Pharmacy and Medicines Institute