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

Phase 2

Completed

• Conditions: Painful Diabetic Neuropathy
• Interventions: Drug: Placebo; Drug: Eslicarbazepine acetate

• Registration Number: NCT00980746
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Results First Submitted: 2013-03-26
• Results First Submitted QC: 2013-03-26
• Results First Posted: 2013-05-22
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 557

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
ESL 600 mg BID	Eslicarbazepine acetate	Eslicarbazepine 600 mg twice daily
ESL 400 mg BID	Eslicarbazepine acetate	ESL 400 mg twice daily (BID)
ESL 800 mg QD	Eslicarbazepine acetate	ESL 800 mg once-daily (QD)
ESL 1200 mg QD	Eslicarbazepine acetate	Eslicarbazepine acetate 1200 mg once daily
ESL 800 mg BID	Eslicarbazepine acetate	Eslicarbazepine acetate 800 mg twice daily

Primary Outcome Measures

Name	Time	Method
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	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.