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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  
Number of Participants  
[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


No publications provided


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