Skip to main content
OpenTrials
Completed

NCT Number: NCT00238524

A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy

This trial was conducted at about 50 sites in Europe and has been clinically completed. Patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an optimized diabetic control and at least moderate pain. Patients were not eligible with other chronic pain or any other medical or psychiatric condition, that would have jeopardized or compromised the patient's ability to participate in the trial. After a 2-week run-in phase patients were randomly assigned to one of three treatment arms. All patients who had completed the 6-week titration phase to reach their target dose entered a 12-week maintenance phase. At the end of the maintenance phase, subjects were offered the option of entering the open-label, follow-on trial. The change in pain was measured daily as well as interference of pain with sleep and general activity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Schwarz

Monheim, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Painful distal diabetic neuropathy

Exclusion criteria

  • Symptoms of painful distal diabetic neuropathy for less than six months or greater than 5 years

Treatment and study plan

SPM 927

Drug

Primary outcomes

  1. Investigate the efficacy of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy will be determined by pain score ratings assessed in a patient's diary and at clinic visits.

Secondary outcomes

  1. Investigate effect of lacosmide on subjects' perception of sleep, activity, quality of life, and safety, determined by rating scales assessed in a patient's diary and at the clinic visits.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day and 600mg/Day SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 13, 2005
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.