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

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

Official Title
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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

Conditions
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Painful Diabetic Neuropathy

Intervention / Treatment
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* Drug: Eslicarbazepine acetate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESL 400 mg BID<br>ESL 400 mg twice daily (BID) | Drug: Eslicarbazepine acetate<br>* Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.<br>* Other names: Zebinix;|
| Experimental: ESL 800 mg QD<br>ESL 800 mg once-daily (QD) | Drug: Eslicarbazepine acetate<br>* Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.<br>* Other names: Zebinix;|
| Experimental: ESL 600 mg BID<br>Eslicarbazepine 600 mg twice daily | Drug: Eslicarbazepine acetate<br>* Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.<br>* Other names: Zebinix;|
| Experimental: ESL 1200 mg QD<br>Eslicarbazepine acetate 1200 mg once daily | Drug: Eslicarbazepine acetate<br>* Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.<br>* Other names: Zebinix;|
| Experimental: ESL 800 mg BID<br>Eslicarbazepine acetate 800 mg twice daily | Drug: Eslicarbazepine acetate<br>* Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.<br>* Other names: Zebinix;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* oral route<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain diabetes neuropathy