adult patients with painful diabetic neuropathy MedDRA version: 9.1 Level: PT Classification code 10012680 Term: Diabetic neuropathy
Conditions
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at screening • 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 Inclusion criteria at randomisation • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy. The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. Oher secondary efficacy variables will be: pain assessed via the sensory portion of the Short-Form McGill Pain Questionnaire (SF-MPQ), Patient Global Impression of Change (PGIC), Clinician Global Impression of Change (CGIC), the dynamic allodynia (evoked pain) assessed by the Allodynia Severity Rating Scale, sleep interference assessed by the Chronic Pain Sleep Inventory (CPSI®), quality of life assessed by the SF-36 Health Survey, and intake of rescue medication.;Secondary Objective: The secondary objectives of the study are to assess the safety, tolerability, and the potential for drug-drug pharmacokinetic interactions of ESL in patients with painful diabetic neuropathy. The safety/tolerability variables will be: adverse events (AEs), standard laboratory safety data (haematology, biochemistry), 12-lead electrocardiogram (ECG), vital signs (blood pressure, heart rate), physical and neurological examinations. The pharmacokinetic variables will be the plasma concentrations of eslicarbazepine (active metabolite of eslicarbazepine acetate) and anti-diabetic drugs;Primary end point(s): Pian intensity of neuropathic pain of diabetic origin will be assessed during treatment period. Change from mean pain from baseline to end of treatment will be the endpoint. | — |
Countries
Austria, Czech Republic, Germany, Hungary, Portugal
Outcome results
None listed