Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain
Condition: Painful Diabetic Neuropathy
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: Eslicarbazepine acetate (BIA 2-093); Placebo
Intervention description: Tablets will be used.; Tablets will be used.
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Neuropathic Pain

Summary:

      The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate
      (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment
      phase.
    

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.

          -  Diagnosis of Type 1 or Type 2 diabetes mellitus.

          -  Pain due to bilateral peripheral polyneuropathy caused by Type 1 or Type 2 diabetes
             mellitus.

          -  Have stable glycemic control, as assessed by the investigator, and have glycosylated
             hemoglobin proportion of less or equal than 11% before randomization.

          -  A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity
             assessment and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days).

          -  Compliance with patient diary completion.

          -  If not used to treat DNP, 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).

          -  Peripheral vascular disease with a history of amputation, except amputation of toes.

          -  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 disorders.

          -  Serious or unstable disease that could compromise participation 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 treatment for DNP.

          -  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.