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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00981227
First received: September 18, 2009
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia
Drug: Eslicarbazepine acetate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain [ Time Frame: baseline and 13 weeks ] [ Designated as safety issue: No ]

    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.


Other Outcome Measures:
  • Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose [ Time Frame: baseline and 13 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 567
Study Start Date: November 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESL 400 mg twice-daily
ESL 400 mg twice-daily
Drug: Eslicarbazepine acetate
Scored tablets
Other Name: Zebinix
Experimental: ESL 800 mg once-daily
ESL 800 mg once-daily
Drug: Eslicarbazepine acetate
Scored tablets
Other Name: Zebinix
Experimental: ESL 600 mg twice daily
ESL 600 mg twice daily
Drug: Eslicarbazepine acetate
Scored tablets
Other Name: Zebinix
Experimental: ESL 1200 mg once daily
ESL 1200 mg once daily
Drug: Eslicarbazepine acetate
Scored tablets
Other Name: Zebinix
Experimental: ESL 800 mg twice daily
ESL 800 mg twice daily
Drug: Eslicarbazepine acetate
Scored tablets
Other Name: Zebinix
Placebo Comparator: placebo
placebo
Drug: Placebo
oral route

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00981227     History of Changes
Other Study ID Numbers: BIA-2093-207
Study First Received: September 18, 2009
Results First Received: February 7, 2013
Last Updated: June 14, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Bial - Portela C S.A.:
pain herpetic neuralgia

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Eslicarbazepine acetate
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014