Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01124097
First received: May 3, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Post-herpetic Neuralgia (PHN) over a 15 week treatment phase.


Condition Intervention Phase
Post Herpetic Neuralgia
Drug: Eslicarbazepine acetate (BIA 2-093)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline to Endpoint in Mean Pain [ Time Frame: baseline to endpoint ] [ Designated as safety issue: No ]

    The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis.

    The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 ["0" = no pain; "10" = the most intense pain imaginable]



Enrollment: 240
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eslicarbazepine acetate 800 mg once daily (QD) Drug: Eslicarbazepine acetate (BIA 2-093)
Tablets will be used.
Other Names:
  • Exalief
  • Zebinix
  • BIA 2-093
  • ESL
Experimental: Eslicarbazepine acetate 1200 mg QD Drug: Eslicarbazepine acetate (BIA 2-093)
Tablets will be used.
Other Names:
  • Exalief
  • Zebinix
  • BIA 2-093
  • ESL
Experimental: Eslicarbazepine acetate 1600 mg QD Drug: Eslicarbazepine acetate (BIA 2-093)
Tablets will be used.
Other Names:
  • Exalief
  • Zebinix
  • BIA 2-093
  • ESL
Placebo Comparator: Placebo Drug: Placebo
Tablets will be used.

Detailed Description:

Post-herpetic neuralgia (PHN) is a syndrome of intractable pain following an acute infection of herpes zoster (shingles).

Treatment for PHN is often suboptimal. More than 50% of the subjects fail to respond to pharmacological treatments or experience intolerable side effects.

The clinical development of ESL to treat neuropathic pain is based on its chemical and pharmacodynamic relationship to sodium channel blockers, including carbamazepine, which is effective for treating some neuropathic pain conditions. Preclinical data supports the theoretical background.

This study will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine acetate for the treatment of post herpetic neuralgia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female outpatients aged 18 years or older. Female subjects are of nonchildbearing potential, defined as surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or at least 2 years postmenopausal (spontaneous amenorrhea for at least 24 months before Visit 1), or if of childbearing potential, subjects agree to use a medically acceptable nonhormonal method of contraception.
  • Experiencing pain for at least 6 months after the healing of a herpes zoster skin rash.
  • A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment.
  • Compliance with patient diary completion.
  • If not used to treat PHN, subjects are permitted to take nonsteroidal anti inflammatory drugs and selective serotonin reuptake inhibitors if they were kept on a stable dose for 1 month prior to Screening and are foreseen to remain stable throughout the study.
  • Competent and able to freely give own informed consent.
  • Female subjects of childbearing potential, who are not currently breastfeeding, must have a negative serum pregnancy test at Visit 1.

Exclusion Criteria:

  • Historical exposure to drugs known to cause neuropathy
  • Significant skin lesions (active infection, ulcer, etc).
  • Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications.
  • Subjects who previously participated in a clinical study with ESL.
  • Major psychiatric disorder.
  • Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study.
  • Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator.
  • Subjects taking the following drug classes and individual drugs are excluded: benzodiazepines (except short half life sleep agents), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletine, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants, tricyclic antidepressants, and serotonin norepinephrine reuptake inhibitors. These drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide.
  • Relevant clinical laboratory abnormality that, in the investigator's opinion, can compromise the subject's safety.
  • History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine.
  • Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry.
  • History of recurrent epileptic seizures except febrile seizures.
  • History of severe gastroparesis or gastric bypass surgery.
  • Neurolytic or neurosurgical treatment for PHN.
  • Injected anesthetics or steroid use within 30 days of Visit 1.
  • Malignancy within past 2 years.
  • History of chronic hepatitis B or C within the past 3 months or human immunodeficiency virus infection.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124097

Locations
Germany
Synexus ClinPharm GmbH
Berlin, Germany, 12627
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01124097     History of Changes
Other Study ID Numbers: BIA-2093-308, 2010-019101-42
Study First Received: May 3, 2010
Results First Received: January 10, 2014
Last Updated: February 26, 2014
Health Authority: Austria: Ethikkommission
Germany: Federal Institute for Drugs and Medical Devices
Chile: Instituto de Salud Pública de Chile
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Israel: Ministry of Health
Poland: Ministry of Health
Mexico: Secretaria de Salud
Russia: Pharmacological Committee, Ministry of Health
India: Ministry of Health
South Africa: Medicines Control Council
Czech Republic: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014