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

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ClinicalTrials.gov Identifier: NCT00980746
Recruitment Status : Completed
First Posted : September 21, 2009
Results First Posted : May 22, 2013
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Drug: Eslicarbazepine acetate Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 557 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ESL 400 mg BID
ESL 400 mg twice daily (BID)
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 (QD)
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




Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 Numeric rating pain scale (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

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
First Posted: September 21, 2009    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: June 22, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Pain
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eslicarbazepine acetate
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action