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

Phase 2

Completed

• Conditions: Painful Diabetic Neuropathy
• Interventions: Other: Placebo; Drug: SPM927/Lacosamide

• Registration Number: NCT00861445
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2003-01
• Study Completion: 2003-02
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Status Verified: 2010-07
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	SPM927/Lacosamide	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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