Clinical trial NCT01124097: Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia
Official title: A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Post Herpetic Neuralgia
Keywords: post herpetic neuralgia
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline to Endpoint in Mean Pain
timeFrame: baseline to endpoint
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Synexus ClinPharm GmbH
Study officials:
References: