Back to resultsEfficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
Primary Purpose
Painful Diabetic Neuropathy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Eslicarbazepine acetate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring pain diabetes neuropathy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ESL 400 mg BID
ESL 800 mg QD
ESL 600 mg BID
ESL 1200 mg QD
ESL 800 mg BID
Placebo
Arm Description
ESL 400 mg twice daily (BID)
ESL 800 mg once-daily (QD)
Eslicarbazepine 600 mg twice daily
Eslicarbazepine acetate 1200 mg once daily
Eslicarbazepine acetate 800 mg twice daily
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00980746
Brief Title
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
pain diabetes neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
557 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESL 400 mg BID
Arm Type
Experimental
Arm Description
ESL 400 mg twice daily (BID)
Arm Title
ESL 800 mg QD
Arm Type
Experimental
Arm Description
ESL 800 mg once-daily (QD)
Arm Title
ESL 600 mg BID
Arm Type
Experimental
Arm Description
Eslicarbazepine 600 mg twice daily
Arm Title
ESL 1200 mg QD
Arm Type
Experimental
Arm Description
Eslicarbazepine acetate 1200 mg once daily
Arm Title
ESL 800 mg BID
Arm Type
Experimental
Arm Description
Eslicarbazepine acetate 800 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine acetate
Other Intervention Name(s)
Zebinix
Intervention Description
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral route
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
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