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

Painful Diabetic Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980746
• Other study ID #: BIA-2093-206
• Secondary ID: EudraCT 2007-002
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2009
• Last updated: March 26, 2013
• Start date: November 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2013
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy

Intervention

Drug:
• Eslicarbazepine acetate
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
• Placebo
oral route

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No