A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy

Official Title
-----------------
A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

Conditions
-----------------
Painful Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: SPM927/Lacosamide
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SPM927/Lacosamide<br>* SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks<br>|
| Placebo Comparator: 2<br> | Other: Placebo<br>* Placebo tablets two times a day for 10 weeks<br>* Other names: Vimpat®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lacosamide, Vimpat®