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Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain

A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain

NCT01129960•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 Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase.

Detailed Description

Diabetic neuropathic pain (DNP) is one of the most common complications of diabetes mellitus. It currently affects about 1% of the population but its prevalence is expected to increase in coming years (European Medicines Agency 2007) in step with the increase in diabetes mellitus prevalence, which is expected to affect 220 million people by 2010 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 diabetic neuropathic pain.

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.
•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.
+8 more criteria

Locations (1)

BIAL - Portela & Cª, S.A.

S. Mamede Do Coronado, S. Mamede Do Coronado, Portugal

Key Dates

Start Date

November 1, 2010

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

July 18, 2014

Enrollment

332

ACTUAL participants

Conditions

Painful Diabetic Neuropathy

Interventions

Eslicarbazepine acetate (BIA 2-093)

DRUG

Placebo

DRUG

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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: July 18, 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 Diabetic Neuropathic Pain

Inclusion Criteria

Exclusion Criteria

Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

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