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

NCT ID: NCT00980746

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 557 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-11-30

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.

Conditions

Painful Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ESL 400 mg BID

ESL 400 mg twice daily (BID)

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.

ESL 800 mg QD

ESL 800 mg once-daily (QD)

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.

ESL 600 mg BID

Eslicarbazepine 600 mg twice daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.

ESL 1200 mg QD

Eslicarbazepine acetate 1200 mg once daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.

ESL 800 mg BID

Eslicarbazepine acetate 800 mg twice daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral route

Interventions

Eslicarbazepine acetate

Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.

Intervention Type: DRUG

Placebo

oral route

Intervention Type: DRUG

Other Intervention Names

Zebinix

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EudraCT 2007-002461-12

Identifier Type: -

Identifier Source: secondary_id

BIA-2093-206

Identifier Type: -

Identifier Source: org_study_id