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

• ClinicalTrials.gov Identifier: NCT00980746
• Recruitment Status: Completed
• First Posted: September 21, 2009
• Results First Posted: May 22, 2013
• Last Update Posted: June 22, 2016
• Sponsor: Bial - Portela C S.A.
• Information provided by (Responsible Party): Bial - Portela C S.A.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Painful Diabetic Neuropathy	Drug: Eslicarbazepine acetate; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 557 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: November 2007
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Zebinix
Placebo Comparator: Placebo; Placebo	Drug: Placebo; oral route

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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.

Eligibility Criteria

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT00980746
• Other Study ID Numbers: BIA-2093-206; EudraCT 2007-002461-12
• First Posted: September 21, 2009
• Results First Posted: May 22, 2013
• Last Update Posted: June 22, 2016
• Last Verified: May 2016

Keywords provided by Bial - Portela C S.A.:

pain diabetes neuropathy

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eslicarbazepine acetate; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action