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Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00981227
First Posted: September 22, 2009
Last Update Posted: October 29, 2014
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: February 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Postherpetic Neuralgia
Interventions: Drug: Eslicarbazepine acetate
Drug: Placebo

  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

First subject enrolled 06 November 2007; Date last subject completed: 19 January 2009.

Number of subjects:

Planned: 540 subjects (90 in each of the 6 treatment groups). Randomised and treated: 567. Analysed for efficacy (per–protocol): 396 Analysed for safety: 567.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
An up to 2–week baseline was followed by a 1–week titration period, an 8–week maintenance period, and a 2–week safety follow–up period. If subjects had a creatinine clearance between 30 and 60 mL/min, they received half of the assigned dose, and subjects with a creatinine clearance below 30 mL/min were not enrolled in this study.

Reporting Groups
  Description
ESL 1200 mg Once Daily

ESL 1200 mg once daily

Eslicarbazepine acetate : Scored tablets

ESL 400 mg Twice-daily

ESL 400 mg twice-daily

Eslicarbazepine acetate : Scored tablets

ESL 600 mg Twice Daily

ESL 600 mg twice daily

Eslicarbazepine acetate : Scored tablets

ESL 800 mg Once-daily

ESL 800 mg once-daily

Eslicarbazepine acetate : Scored tablets

ESL 800 mg Twice Daily

ESL 800 mg twice daily

Eslicarbazepine acetate : Scored tablets

Placebo

placebo

Placebo : oral route


Participant Flow:   Overall Study
    ESL 1200 mg Once Daily   ESL 400 mg Twice-daily   ESL 600 mg Twice Daily   ESL 800 mg Once-daily   ESL 800 mg Twice Daily   Placebo
STARTED   102   94   94   94   90   93 
Randomized   102   94   94   94   90   93 
Safety Population   102   94   94   94   90   93 
Per–Protocol   69   72   67   68   50   70 
COMPLETED   80   75   73   73   60   75 
NOT COMPLETED   22   19   21   21   30   18 



  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

ESL 1200 mg once daily

Eslicarbazepine acetate : Scored tablets

ESL 400 mg Twice-daily

ESL 400 mg twice-daily

Eslicarbazepine acetate : Scored tablets

ESL 600 mg Twice Daily

ESL 600 mg twice daily

Eslicarbazepine acetate : Scored tablets

ESL 800 mg Once-daily

ESL 800 mg once-daily

Eslicarbazepine acetate : Scored tablets

ESL 800 mg Twice Daily

ESL 800 mg twice daily

Eslicarbazepine acetate : Scored tablets

Placebo

placebo

Placebo : oral route

Total Total of all reporting groups

Baseline Measures
   ESL 1200 mg Once Daily   ESL 400 mg Twice-daily   ESL 600 mg Twice Daily   ESL 800 mg Once-daily   ESL 800 mg Twice Daily   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 102   94   94   94   90   93   567 
Age, Customized 
[Units: Participants]
             
<=18 years   0   0   0   0   0   0   0 
Between 18 and 65 years   34   36   35   37   30   38   210 
>=65 years   68   58   59   57   60   55   357 
Gender 
[Units: Participants]
             
Female   69   55   57   52   64   44   341 
Male   33   39   37   42   26   49   226 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain   [ Time Frame: baseline and 13 weeks ]

2.  Other Pre-specified:   Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose   [ Time Frame: baseline and 13 weeks ]


  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
No text entered.


  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 6100
e-mail: clinical.trials@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00981227     History of Changes
Other Study ID Numbers: BIA-2093-207
First Submitted: September 18, 2009
First Posted: September 22, 2009
Results First Submitted: February 7, 2013
Results First Posted: May 3, 2013
Last Update Posted: October 29, 2014