A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY AND SAFETY OF 400MG/DAY LACOSAMIDE IN SUBJECTS WITH PAINFUL DISTAL DIABETIC NEUROPATHY USING TWO DIFFERENT TITRATION SCHEMES - ND

• Conditions: Painful distal diabetic neuropathy; MedDRA version: 9.1Level: HLGTClassification code 10012653Term: Diabetic complications

• Registration Number: EUCTR2005-005788-27-IT
• Lead Sponsor: SCHWARZ PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 765

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, 61619;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 12 , which is optimized best effort to achieve best control for at least 3 months prior to Visit 1. 6. Subject has at least moderate pain that is defined as an average pain intensity of 61619;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

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 61619;2 times the upper limit of normal ULN or has alkaline phosphatase levels 61619;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 61619;470ms at Visit 1, where QTc is based on a central cardiologist overread. 13. Subject has 2 61616; or 3 61616; atrioventricular block or sinus bradycardia heart rate 50 beats per minute bpm or sinus tachycardia heart rate 110bpm at Visit 1, based on a central cardiologist overread. 14. Subject has diastolic blood pressure 50mm Hg or 105mm Hg, measured in a sitting position after 3 minutes at rest. 15. Subject has known hypersensitivity to any components of the trial medication or rescue medication as stated in this protocol. 16. Subject is a pregnant or nursing female, or is of childbearing potential and does not practice adequate methods of contraception eg, implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner . Women who are surgically sterile uterus removed or both tubes tied or postmenopausal at least 2 years without periods are allowed to participate in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 .;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.