Painful Diabetic Neuropathy
Conditions
Keywords
Lacosamide, Vimpat®
Brief summary
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
Interventions
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks
OTHERPlacebo
Placebo tablets two times a day for 10 weeks
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II). * Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale). * subjects must have good or fair diabetic control (Hgb A1c \< 10%)
Exclusion criteria
* Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease. * Subject receives treatment for seizures. * Subject has had any amputations other than diabetically-related toe amputations. * Subject has major skin ulcers. * Subject has clinically significant ECG abnormalities. * Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties. * Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant. * At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal. * subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy | Assessments throughout the trial, either daily and/or at clinic visits |
Secondary
| Measure | Time frame |
|---|---|
| Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
| Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
| Investigate the tolerability and safety of SPM927 (assessment during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
| Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation) | Daily assessment during entire trial participation including visits at the site |
Outcome results
None listed