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

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

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

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: Eslicarbazepine acetate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 567
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose	Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 "no pain" to 10 "worst possible pain") NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting.	baseline and 13 weeks

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: September 18, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 21, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: pain herpetic neuralgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: BIA-2093-207