Clinical trial NCT00861445: A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
Official title: A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Keywords: Lacosamide, Vimpat®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy


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.

Primary outcomes:
measure: The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
timeFrame: Assessments throughout the trial, either daily and/or at clinic visits
Secondary outcomes:
measure: Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)
timeFrame: Daily assessment during entire trial participation including visits at the site
measure: Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)
timeFrame: Daily assessment during entire trial participation including visits at the site
measure: Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)
timeFrame: Daily assessment during entire trial participation including visits at the site
measure: Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
timeFrame: Daily assessment during entire trial participation including visits at the site
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2.