Painful distal diabetic neuropathy MedDRA version: 6.0 Level: LLT Classification code 10012680
Conditions
Interventions
Product Name: Lacosamide
Product Code: SPM 929
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lacosamide
CAS Number: 17548
Sponsors
SCHWARZ BIOSCIENCES GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must fulfill the following inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. 2. Subject is willing and able to comply with all trial requirements. 3. Subject is male or female, >=18 years of age. 4. Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II). Subjects who have had symptoms of painful diabetic neuropathy for longer than 5 years may only be enrolled after consultation with the Medical Monitor. 5. Subject has good to fair diabetic control (glycosylated hemoglobin A1c [HbA1c] levels =4 on an 11 point Likert scale (0-10) during the 7 days prior to Visit 2, where at least 4 out of the 7 days have both the morning and evening scores recorded. 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: Subjects are not permitted to enroll in the trial if any of the following criteria are met: 1. Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial. 2. Subject has participated in another trial of an investigational drug (or a medical device) within the last 30 days or is currently participating in another trial of an investigational drug or medical device. 3. Subject has other conditions that cause chronic pain at least as severe as the diabetic neuropathy pain, unless subject can clearly distinguish the different types of pain. These cases should be discussed with the medical monitor. 4. Subject is expected to take within 7 days prior to randomization or during the trial AEDs, muscle relaxants, mexiletine, topical analgesics, opioids or unstable doses of tricyclic antidepressants (TCAs), or any other approved therapy for treating painful diabetic neuropathy (such as duloxetine). Paracetamol up to 2g/day is allowed as rescue medication during the entire trial. 5. Subject is receiving treatment with neurostimulating devices such as spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS). Treatment for pain with acupuncture, surgery, or blockade not allowed. 6. Subject has had an amputation related to diabetes, other than toe amputations. 7. Subject has major skin ulcers. 8. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin levels >=2 times the upper limit of normal (ULN) or has alkaline phosphatase levels >=3 times the ULN at Visit 1. 9. Subject has impaired renal function, ie, creatinine clearance (Ccr) is lower than 50mL/min at Visit 1. Creatinine clearance will be estimated as follows: Adult males: Ccr = (140-age) x weight in kg/(72 x serum creatinine in mg/dL) Adult females: Ccr = [(140-age) x weight in kg/(72 x serum creatinine in mg/dL)] x .85. 10. Subject has other laboratory values, which are outside the normal range at Visit 1 and judged by the investigator as clinically relevant. Exceptions are out-of-range values that are expected in this diabetic population (eg, elevated glucose). 11. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months, or has any cardiac disorder that, in the opinion of the investigator, would put the subject at risk of clinically relevant arrhythmia and/or myocardial infarction. 12. Subject has a QTc >=470ms at Visit 1, where QTc is based on a central cardiologist overread. 13. Subject has 2° or 3° atrioventricular block or sinus bradycardia (heart rate 110bpm) at Visit 1, based on a central cardiologist overread. 14. Subject has diastolic blood pressure 105mm Hg, measured in a sitting position after 3 minutes at rest. 15. Subject has a history of alcohol or drug abuse within the last year. 16. Subject has scheduled or expects to schedule a surgical procedure during the course of the trial. 17. Subject has any medical or psychiatric condition that, in the opinion of the invest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to investigate the efficacy of 400mg/day of LCM compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. Two titration schemes will be used; the first is a standard titration scheme such that the target dose of 400mg/day is attained at Day 22, the second is a more rapid titration scheme and the target dose of 400mg/day is attained at Day 8. Each titration scheme will be compared with placebo.;Secondary Objective: Secondary objectives are to investigate the onset of action under treatment of LCM, the effect of LCM on subjects’ perception of pain, sleep, activity, and quality of life, and to further investigate the safety of LCM.;Primary end point(s): The primary efficacy variable is the within-subject change in average daily pain score from the Baseline week to the last 4 weeks of the Maintenance Phase using an 11-point Likert scale (0-10). | — |
Countries
Austria, Czech Republic, Finland, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed