Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00980746
First received: September 18, 2009
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.


Condition Intervention Phase
Painful Diabetic Neuropathy
Drug: Eslicarbazepine acetate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2 093) as Therapy for Patients With Painful Diabetic Neuropathy: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.


Enrollment: 557
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESL 400 mg BD
ESL 400 mg twice daily
Drug: Eslicarbazepine acetate
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Other Name: Zebinix
Experimental: ESL 800 mg QD
ESL 800 mg once-daily
Drug: Eslicarbazepine acetate
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Other Name: Zebinix
Experimental: ESL 600 mg BID
Eslicarbazepine 600 mg twice daily
Drug: Eslicarbazepine acetate
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Other Name: Zebinix
Experimental: ESL 1200 mg QD
Eslicarbazepine acetate 1200 mg once daily
Drug: Eslicarbazepine acetate
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Other Name: Zebinix
Experimental: ESL 800 mg BID
Eslicarbazepine acetate 800 mg twice daily
Drug: Eslicarbazepine acetate
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Other Name: Zebinix
Placebo Comparator: Placebo
Placebo
Drug: Placebo
oral route

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent to participate in the study
  • Men and women aged 18 years or older
  • Diagnosis of diabetes mellitus Type 1 or 2
  • Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
  • Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
  • Cooperation and willingness to complete all aspects of the study
  • Completion of at least 4 daily diaries during the week preceding randomisation
  • A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

  • Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
  • Significant or unstable medical or psychiatric disorders
  • Drug or alcohol abuse in the preceding 2 years
  • Peripheral vascular disease with a history of amputation, except amputation of toes
  • Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
  • Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
  • Previous participation in any study with eslicarbazepine acetate
  • Pregnancy or breast feeding
  • History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
  • History of non-compliance
  • Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
  • Participation in a clinical study within 3 months prior to screening
  • Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00980746     History of Changes
Other Study ID Numbers: BIA-2093-206, EudraCT 2007-002461-12
Study First Received: September 18, 2009
Results First Received: March 26, 2013
Last Updated: March 26, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Bial - Portela C S.A.:
pain diabetes neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 17, 2014