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Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01129960
Recruitment Status : Terminated
First Posted : May 25, 2010
Results First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Painful Diabetic Neuropathy
Interventions: Drug: Eslicarbazepine acetate (BIA 2-093)
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Fifty nine (59) clinical sites in 10 countries

Study period:

Date of first admission: 2010.12.06 Date of last visit: 2012.04.24


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
Esl 1600 mg Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
Esl 1200 mg Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
Esl 800 mg Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
Placebo Placebo: Tablets will be used.

Participant Flow:   Overall Study
    Esl 1600 mg   Esl 1200 mg   Esl 800 mg   Placebo
STARTED   84   83   82   83 
Safety   84   83   83 [1]   82 
Intent-to-Treat   84   83   82   83 
Per-Protocol   34   52   49   55 
Full Analysis Set (FAS   71   67   68   71 
COMPLETED   54   61   56   70 
NOT COMPLETED   30   22   26   13 
Withdrawal by Subject                3                0                3                2 
Lack of Efficacy                1                1                1                1 
Adverse Event                23                16                16                7 
Protocol Violation                1                2                3                0 
Lost to Follow-up                0                2                3                3 
Discontinuation of the study by Sponsor                0                1                0                0 
Physician Decision                1                0                0                0 
Pregnancy                1                0                0                0 
[1] One subject was randomized to placebo, but was dispensed in error with an ESL 800 mg kit at DB Visit



  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
Esl 1600 mg Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
Esl 1200 mg Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
Esl 800 mg Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
Placebo Placebo: Tablets will be used.
Total Total of all reporting groups

Baseline Measures
   Esl 1600 mg   Esl 1200 mg   Esl 800 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   83   83   82   332 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (10.93)   59.0  (11.38)   58.0  (13.33)   59.5  (10.25)   58.5  (11.51) 
Gender 
[Units: Participants]
         
Female   45   35   37   33   150 
Male   39   48   46   49   182 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   55   50   55   50   210 
Black   2   3   1   2   8 
Asian   26   28   25   24   103 
Other   1   2   2   6   11 


  Outcome Measures

1.  Primary:   Change From Baseline to Endpoint in Mean Pain   [ Time Frame: baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase) ]


  Serious Adverse Events


  Other Adverse Events


  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

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: 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: NCT01129960     History of Changes
Other Study ID Numbers: BIA-2093-307
2010-019100-23 ( EudraCT Number )
First Submitted: May 3, 2010
First Posted: May 25, 2010
Results First Submitted: January 10, 2014
Results First Posted: July 18, 2014
Last Update Posted: July 18, 2014