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Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00957047
First received: August 10, 2009
Last updated: June 23, 2014
Last verified: June 2014
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);   Primary Purpose: Treatment
Condition: Partial Epilepsy
Interventions: Drug: eslicarbazepine acetate
Drug: placebo
Drug: ESL - Part II

  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 DATES:

PART I - From: 01 Sep 2004 To: 19 Dec 2006; PART II - From: 02 February 2005 To: 29 January 2008 Patients were screened at 46 sites in 13 countries for Part I and Patients from 42 sites in 12 countries continued in part II.;


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part I was a 22-week parallel-group, randomized, placebo controlled period. After completing the baseline period, patients were randomized in a 1:1:1:1 ratio to 1 of the 3 ESL dose levels or to placebo. For Part I 400 patients were planned; of 503 patients screened, 395 were randomized. 325 patients who completed Part I were enrolled in Part II.

Reporting Groups
  Description
Placebo placebo : once daily placebo comparator
ESL 400 mg Once Daily eslicarbazepine acetate : oral tablets
ESL 800 mg Once Daily eslicarbazepine acetate : oral tablets
ESL 1200 mg Once Daily eslicarbazepine acetate : oral tablets
ESL - Part II All patients in Part II received ESL on an open-label basis, starting at 800 mg once daily.

Participant Flow for 2 periods

Period 1:   PART I
    Placebo   ESL 400 mg Once Daily   ESL 800 mg Once Daily   ESL 1200 mg Once Daily   ESL - Part II
STARTED   100   96   101   98   0 
Randomized/Safety Population   100   96   101   98   0 
Intention-to-treat (ITT) Population   100   96   100   97   0 
Per-Protocol Population   81   70   75   54   0 
COMPLETED   94   83   80   68   0 
NOT COMPLETED   6   13   21   30   0 

Period 2:   PART II
    Placebo   ESL 400 mg Once Daily   ESL 800 mg Once Daily   ESL 1200 mg Once Daily   ESL - Part II
STARTED   0   0   0   0   325 [1] 
Terminated Prematurely   0   0   0   0   102 [2] 
COMPLETED   0   0   0   0   223 
NOT COMPLETED   0   0   0   0   102 
[1] 325 patients who completed Part I were enrolled in Part II.
[2] Terminated Prematurely during 1-year Open-Label Period



  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 Once Daily eslicarbazepine acetate : oral tablets
ESL 400 mg Once Daily eslicarbazepine acetate : oral tablets
ESL 800 mg Once Daily eslicarbazepine acetate : oral tablets
Placebo placebo : once daily placebo comparator
Total Total of all reporting groups

Baseline Measures
   ESL 1200 mg Once Daily   ESL 400 mg Once Daily   ESL 800 mg Once Daily   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   96   101   100   395 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   98   96   101   98   393 
>=65 years   0   0   0   2   2 
Gender 
[Units: Participants]
         
Female   46   57   50   48   201 
Male   52   39   51   52   194 


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

2.  Primary:   PART II - Nº of Treatment-Emergent Adverse Events (TEAE)   [ Time Frame: 1 year ]


  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 Section
Organization: Bial - Portela & Cª, S.A.
phone: + 351 22 986 61 00
e-mail: clinical.trials@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00957047     History of Changes
Other Study ID Numbers: BIA-2093-302
Study First Received: August 10, 2009
Results First Received: March 26, 2013
Last Updated: June 23, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute