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
Overview
- Phase
- Phase 2
- Intervention
- Eslicarbazepine acetate
- Conditions
- Painful Diabetic Neuropathy
- Sponsor
- Bial - Portela C S.A.
- Enrollment
- 557
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Arms & Interventions
ESL 400 mg BID
ESL 400 mg twice daily (BID)
Intervention: Eslicarbazepine acetate
ESL 800 mg QD
ESL 800 mg once-daily (QD)
Intervention: Eslicarbazepine acetate
ESL 600 mg BID
Eslicarbazepine 600 mg twice daily
Intervention: Eslicarbazepine acetate
ESL 1200 mg QD
Eslicarbazepine acetate 1200 mg once daily
Intervention: Eslicarbazepine acetate
ESL 800 mg BID
Eslicarbazepine acetate 800 mg twice daily
Intervention: Eslicarbazepine acetate
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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.