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

BIAL

Status and phase: Completed; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Placebo; Drug: Eslicarbazepine acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00980746

EudraCT 2007-002461-12

BIA-2093-206

Details and patient eligibility

About

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

Enrollment: 557 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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557 participants in 6 patient groups, including a placebo group

ESL 400 mg BID

Experimental group

Description:

ESL 400 mg twice daily (BID)

Treatment:

Drug: Eslicarbazepine acetate

ESL 800 mg QD

Experimental group

Description:

ESL 800 mg once-daily (QD)

Treatment:

Drug: Eslicarbazepine acetate

ESL 600 mg BID

Experimental group

Description:

Eslicarbazepine 600 mg twice daily

Treatment:

Drug: Eslicarbazepine acetate

ESL 1200 mg QD

Experimental group

Description:

Eslicarbazepine acetate 1200 mg once daily

Treatment:

Drug: Eslicarbazepine acetate

ESL 800 mg BID

Experimental group

Description:

Eslicarbazepine acetate 800 mg twice daily

Treatment:

Drug: Eslicarbazepine acetate

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo