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TERMINATEDPHASE3

Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia

A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia

NCT01124097•Bial - Portela C S.A.

View on ClinicalTrials.gov

Summary

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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

Locations (1)

Synexus ClinPharm GmbH

Berlin, State of Berlin, Germany

Key Dates

Start Date

September 1, 2010

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

April 7, 2014

Enrollment

240

ACTUAL participants

Conditions

Post Herpetic Neuralgia

Interventions

Eslicarbazepine acetate (BIA 2-093)

DRUG

Placebo

DRUG

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RECRUITINGPHASE1

A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia

Inclusion Criteria

Exclusion Criteria

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.

Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.

Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.

Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia