Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia

NCT ID: NCT01124097

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-04-30

Brief 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.

Conditions

Post Herpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Eslicarbazepine acetate 800 mg once daily (QD)

Group Type: EXPERIMENTAL

Eslicarbazepine acetate (BIA 2-093)

Intervention Type: DRUG

Tablets will be used.

Eslicarbazepine acetate 1200 mg QD

Group Type: EXPERIMENTAL

Eslicarbazepine acetate (BIA 2-093)

Intervention Type: DRUG

Tablets will be used.

Eslicarbazepine acetate 1600 mg QD

Group Type: EXPERIMENTAL

Eslicarbazepine acetate (BIA 2-093)

Intervention Type: DRUG

Tablets will be used.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets will be used.

Interventions

Eslicarbazepine acetate (BIA 2-093)

Tablets will be used.

Intervention Type: DRUG

Placebo

Tablets will be used.

Intervention Type: DRUG

Other Intervention Names

Exalief; Zebinix; BIA 2-093; ESL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Synexus ClinPharm GmbH

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

2010-019101-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIA-2093-308

Identifier Type: -

Identifier Source: org_study_id