Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01129960
First received: May 3, 2010
Last updated: November 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathic Pain
Drug: Eslicarbazepine acetate (BIA 2-093)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • To assess the efficacy of ESL as therapy in subjects with Diabetic Neuropathic Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary efficacy variable will be based on the response to a 11 point 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 Outcome Measures:
  • 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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pain intensity (calculated from the 11-point NRPS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Responder rates (reduction of at least 30% or at least 50% compared with baseline based on the 11-point NRPS average pain score). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient and clinical global impression of change (subjects rate their change in the overall status answering the question on the scale). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Short Form McGill Pain Questionnaire (subjects complete this questionnaire as a qualitative assessment of their pain and their affective response to pain). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Allodynia Visual Analog Scale (subjects rate the allodynia severity after mechanic allodynia evoked pain). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Chronic Pain Sleep Inventory (subjects complete this inventory to assess the impact of their pain on sleep). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 468
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eslicarbazepine acetate 800 mg once daily (QD) Drug: Eslicarbazepine acetate (BIA 2-093)
Tablets will be used.
Other Names:
  • Exalief
  • Zebinix
  • BIA 2-093
  • ESL
Experimental: Eslicarbazepine acetate 1200 mg QD Drug: Eslicarbazepine acetate (BIA 2-093)
Tablets will be used.
Other Names:
  • Exalief
  • Zebinix
  • BIA 2-093
  • ESL
Experimental: Eslicarbazepine acetate 1600 mg QD Drug: Eslicarbazepine acetate (BIA 2-093)
Tablets will be used.
Other Names:
  • Exalief
  • Zebinix
  • BIA 2-093
  • ESL
Placebo Comparator: Placebo Drug: Placebo
Tablets will be used.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129960

Locations
Portugal
BIAL - Portela & Cª, S.A.
S. Mamede do Coronado, Portugal, 4045-457
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01129960     History of Changes
Other Study ID Numbers: BIA-2093-307, 2010-019100-23
Study First Received: May 3, 2010
Last Updated: November 29, 2013
Health Authority: Austria: Ethikkommission
Argentina: Ministry of Health
Chile: Instituto de Salud Publica de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Poland: Ministry of Health
Germany: Ministry of Health

Keywords provided by Bial - Portela C S.A.:
Diabetic Neuropathic Pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014