MedTrace Logo

Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

NCT00135109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2014-09-22

No results posted yet for this study

Summary

This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the start of treatment.

To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

SPM 927

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • United States

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00135109 on ClinicalTrials.gov