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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00988156
First received: October 1, 2009
Last updated: July 16, 2014
Last verified: May 2014
Results First Received: May 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Partial Epilepsy in Children and Adolescents
Interventions: Drug: Eslicarbazepine acetate (BIA 2-093)
Drug: Eslicarbazepine acetate

  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
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
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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
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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
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  
Number of Participants  
[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  
Gender  
[units: participants]
     
Female     67     70     137  
Male     62     64     126  



  Outcome Measures
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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
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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:  
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


No publications provided


Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00988156     History of Changes
Other Study ID Numbers: BIA-2093-305
Study First Received: October 1, 2009
Results First Received: May 9, 2014
Last Updated: July 16, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute