We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988156
First Posted: October 2, 2009
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bial - Portela C S.A.
Results First Submitted: May 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Partial Epilepsy in Children and Adolescents
Interventions: Drug: Eslicarbazepine acetate (BIA 2-093)
Drug: Eslicarbazepine acetate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
73 clinical centres in 20 countries Date first patient enrolled: 07 Dec 2007. Date last patient completed the double-blind treatment period (Part I): 20 Aug 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo matching placebo
Esl (BIA 2-093) Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).

Participant Flow:   Overall Study
    Placebo   Esl (BIA 2-093)
STARTED   149   155 
Intention-to-Treat Set (ITT)   129   134 
Per Protocol Set (PP)   101   97 
Safety Set   129   134 
COMPLETED   132   135 
NOT COMPLETED   17   20 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Placebo Placebo matching placebo
Esl (BIA 2-093) Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
Total Total of all reporting groups

Baseline Measures
   Placebo   Esl (BIA 2-093)   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   134   263 
Age, Customized 
[Units: Participants]
     
2-6 years   31   31   62 
7-11 years   53   51   104 
12-18 years   45   52   97 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      67  51.9%      70  52.2%      137  52.1% 
Male      62  48.1%      64  47.8%      126  47.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Seizure Frequency   [ Time Frame: Baseline up to Visit 7 ]

2.  Primary:   Responder Rate   [ Time Frame: baseline up to Visit 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Director R&D
Organization: BIAL - Portela & Cª, S.A.
phone: 351-22-9866100
e-mail: clinical.trials@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00988156     History of Changes
Other Study ID Numbers: BIA-2093-305
2007-001887-55 ( EudraCT Number )
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: May 9, 2014
Results First Posted: July 17, 2014
Last Update Posted: September 20, 2017