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

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

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

Study Overview

• Status: Completed
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Other: Placebo; Drug: SPM927/Lacosamide

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): January 1, 2003
• Study Completion (Actual): February 1, 2003

Study Registration Dates

• First Submitted: March 12, 2009
• First Submitted That Met QC Criteria: March 12, 2009
• First Posted (Estimate): March 13, 2009

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Lacosamide, Vimpat®
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: SP0614