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

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

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

Study Overview

• Status: Completed
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Drug: Placebo; Drug: Eslicarbazepine acetate

• Study Type: Interventional
• Enrollment (Actual): 557
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral route
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Zebinix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	17 weeks

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: September 18, 2009
• First Submitted That Met QC Criteria: September 18, 2009
• First Posted (Estimate): September 21, 2009

Study Record Updates

• Last Update Posted (Estimate): June 22, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: pain diabetes neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: BIA-2093-206; EudraCT 2007-002461-12