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Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00988429
First received: October 1, 2009
Last updated: October 14, 2015
Last verified: October 2015
Results First Received: December 3, 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: Partial Epilepsy
Interventions: Drug: 800 mg QD Eslicarbazepine acetate
Drug: 1200 mg QD 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

A total of 173 investigational sites in 19 countries (North America, 89 sites; Rest-of-World [ROW], 84 sites) screened and enrolled subjects. Of these, 160 sites randomized subjects into the study.

Studied period (years):

  • First subject first visit: 02 December 2008
  • Last subject last visit: 12 January 2012 (Part I)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The first period was an 8-week observation baseline period (Week -8 to Week -1) during which subjects were instructed on how to complete the seizure diary. At the end of the 8 week observational baseline period, eligible subjects were randomized in a 1:1:1 allocation ratio to 1 of 3 treatment groups (with a blinded treatment assignment)

Reporting Groups
  Description
Placebo Matching placebo tablets QD orally
800 mg QD The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
1200 mg QD The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.

Participant Flow:   Overall Study
    Placebo   800 mg QD   1200 mg QD
STARTED   226   216   211 
Safety Population   224   216   210 
Intention-to-treat (ITT) Population   220   215   205 
COMPLETED   189   173   142 
NOT COMPLETED   37   43   69 
Adverse Event                9                21                45 
Lack of Efficacy                0                0                1 
Non-Compliance with Study Drug                5                1                3 
Physician Decision                1                0                3 
Pregnancy                2                1                0 
Protocol Violation                4                3                3 
Withdrawal by Subject                7                7                12 
Administrative Reasons                1                2                1 
other reasons                8                8                1 



  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.
Data Sets Analyzed: Safety Population (all randomized subjects who received at least one dose of study drug after randomization)

Reporting Groups
  Description
Placebo Matching placebo tablets QD orally
800 mg QD The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
1200 mg QD The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
Total Total of all reporting groups

Baseline Measures
   Placebo   800 mg QD   1200 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 224   216   210   650 
Age 
[Units: Participants]
       
<=18 years   3   2   6   11 
Between 18 and 65 years   218   211   202   631 
>=65 years   3   3   2   8 
Gender 
[Units: Participants]
       
Female   112   107   105   324 
Male   112   109   105   326 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   46   41   39   126 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   8   8   8   24 
White   142   137   134   413 
More than one race   0   0   0   0 
Unknown or Not Reported   28   30   29   87 


  Outcome Measures
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1.  Primary:   Seizure Frequency Over the 12-week Maintenance Period.   [ Time Frame: 12-week maintenance period (Week 3 to week 14) ]

2.  Secondary:   Proportion of Responders   [ Time Frame: Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Head of Clinical Research
Organization: Bial - portela & Cª, S.A.
phone: +351 22 986 6100
e-mail: clinical.trials@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00988429     History of Changes
Other Study ID Numbers: BIA-2093-304
2008-002455-25 ( EudraCT Number )
Study First Received: October 1, 2009
Results First Received: December 3, 2013
Last Updated: October 14, 2015
Health Authority: Brazil: National Health Surveillance Agency
United States: Food and Drug Administration