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

Study Overview
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Brief Summary
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The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.

Official Title
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Efficacy and Safety of Eslicarbazepine Acetate (BIA 2093) as Therapy for Patients With Post-herpetic Neuralgia: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

Conditions
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Postherpetic Neuralgia

Intervention / Treatment
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* Drug: Eslicarbazepine acetate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent to participate in the study Men and women aged 18 years or older Previous diagnosis of herpes zoster Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash Cooperation and willingness to complete all aspects of the study Completion of at least 4 daily diaries during the week preceding randomisation A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation. Exclusion Criteria: Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin Active herpes zoster lesion or dermatitis of any origin at the affected site Subjects who had neurological ablation by block or neurosurgical intervention for control of pain Significant or unstable medical or psychiatric disorders Drug or alcohol abuse in the preceding 2 years Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3) Previous participation in any study with eslicarbazepine acetate Pregnancy or breast feeding History of hypersensitivity to the investigational products or to drugs with a similar chemical structure History of non-compliance Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol Participation in a clinical study within 3 months prior to screening Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESL 400 mg twice-daily<br>ESL 400 mg twice-daily | Drug: Eslicarbazepine acetate<br>* Scored tablets<br>* Other names: Zebinix;|
| Experimental: ESL 800 mg once-daily<br>ESL 800 mg once-daily | Drug: Eslicarbazepine acetate<br>* Scored tablets<br>* Other names: Zebinix;|
| Experimental: ESL 600 mg twice daily<br>ESL 600 mg twice daily | Drug: Eslicarbazepine acetate<br>* Scored tablets<br>* Other names: Zebinix;|
| Experimental: ESL 1200 mg once daily<br>ESL 1200 mg once daily | Drug: Eslicarbazepine acetate<br>* Scored tablets<br>* Other names: Zebinix;|
| Experimental: ESL 800 mg twice daily<br>ESL 800 mg twice daily | Drug: Eslicarbazepine acetate<br>* Scored tablets<br>* Other names: Zebinix;|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo<br>* oral route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours. Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows: Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation. Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period. | baseline and 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain herpetic neuralgia