Health Condition 1: null- Post-Herpetic Neuralgia
Conditions
Interventions
Intervention1: Eslicarbazepine acetate 800 mg once daily (QD)(Oral Tablets): Eslicarbazepine acetate 800 mg once daily (QD): Experimental
19 weeks (Blinded phase) followed by optional open label 36 we
Sponsors
Bial Portela C SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 2. Experiencing pain for at least 6 months after the healing of a herpes zoster skin rash. 3. A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment. 4. Compliance with patient diary completion. 5. 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. 6. Competent and able to freely give own informed consent. 7. Female subjects of childbearing potential, who are not currently breastfeeding, must have a negative serum pregnancy test at Visit 1. Note: There is no upper age limit/restriction for inclusion or exclusion in the study.
Exclusion criteria
Exclusion criteria: 1. Historical exposure to drugs known to cause neuropathy 2. Significant skin lesions (active infection, ulcer, etc). 3. Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications. 4. Subjects who previously participated in a clinical study with ESL. 5. Major psychiatric disorder. 6. Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study. 7. 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. 8. 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. 9. Relevant clinical laboratory abnormality that, in the investigators opinion, can compromise the subjects safety. 10. History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine. 11. 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. 12. History of recurrent epileptic seizures except febrile seizures. 13. History of severe gastroparesis or gastric bypass surgery. 14. Neurolytic or neurosurgical treatment for PHN. 15. Injected anesthetics or steroid use within 30 days of Visit 1. 16. Malignancy within past 2 years. 17. History of chronic hepatitis B or C within the past 3 months or human immunodeficiency virus infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of ESL as therapy in subjects with Post Herpetic NeuralgiaTimepoint: Time Frame: 12 weeks The primary efficacy variable will be based on the response to a 11-point Numerical Rating Pain Scale (NRPS) relating to pain intensity. This will be used to generate the primary efficacy variable of change from Baseline to endpoint in mean pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Allodynia Visual Analog Scale (subjects rate the allodynia severity after mechanic allodynia evoked pain).Timepoint: Time Frame: 12 weeks;Chronic Pain Sleep Inventory (subjects complete this inventory to assess the impact of their pain on sleep).Timepoint: Time Frame: 12 weeks;Patient and clinical global impression of change (subjects rate their change in the overall status answering the question on the scale).Timepoint: Time Frame: 12 weeks;Rescue medication use (number of days from first intake of double-blind study drug to first intake of rescue medication and the mean amount of paracetamol per study day will be derived).Timepoint: Time Frame: 12 weeks;Responder rates (reduction of at least 30% or at least 50% compared with baseline based on the 11-point NRPS average pain score).Timepoint: Time Frame: 12 weeks;Short Form McGill Pain Questionnaire (subjects complete this questionnaire as a qualitative assessment of their pain and their affective response to pain).Timepoint: Time Frame: 12 weeks;Time to response (time in days to the first of 2 consecutive days after randomization with average pain score at least 2 points below baseline mean pain, based on the 11-point NRPS average pain score).Timepoint: Time Frame: 12 weeks;Weekly mean pain intensity (calculated from the 11-point NRPS).Timepoint: Time Frame: 12 weeks;Worst daily pain and worst night pain (change from Baseline to endpoint in worst daily pain and night pain is defined in the same way as the primary efficacy endpoint).Timepoint: Time Frame: 12 weeks | — |
Countries
Argentina, Austria, Chile, Germany, India, Israel, Mexico, Poland, Russian Federation, South Africa, Spain, United Kingdom
Contacts
Public ContactArun Sundriyal
Outcome results
None listed