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

Primary Purpose

Postherpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Eslicarbazepine acetate
Placebo
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring pain herpetic neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    ESL 400 mg twice-daily

    ESL 800 mg once-daily

    ESL 600 mg twice daily

    ESL 1200 mg once daily

    ESL 800 mg twice daily

    placebo

    Arm Description

    ESL 400 mg twice-daily

    ESL 800 mg once-daily

    ESL 600 mg twice daily

    ESL 1200 mg once daily

    ESL 800 mg twice daily

    placebo

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2009
    Last Updated
    October 21, 2014
    Sponsor
    Bial - Portela C S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00981227
    Brief Title
    Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bial - Portela C S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postherpetic Neuralgia
    Keywords
    pain herpetic neuralgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    567 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ESL 400 mg twice-daily
    Arm Type
    Experimental
    Arm Description
    ESL 400 mg twice-daily
    Arm Title
    ESL 800 mg once-daily
    Arm Type
    Experimental
    Arm Description
    ESL 800 mg once-daily
    Arm Title
    ESL 600 mg twice daily
    Arm Type
    Experimental
    Arm Description
    ESL 600 mg twice daily
    Arm Title
    ESL 1200 mg once daily
    Arm Type
    Experimental
    Arm Description
    ESL 1200 mg once daily
    Arm Title
    ESL 800 mg twice daily
    Arm Type
    Experimental
    Arm Description
    ESL 800 mg twice daily
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Eslicarbazepine acetate
    Other Intervention Name(s)
    Zebinix
    Intervention Description
    Scored tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    oral route
    Primary Outcome Measure Information:
    Title
    Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain
    Description
    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.
    Time Frame
    baseline and 13 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose
    Description
    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.
    Time Frame
    baseline and 13 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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