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

September 19, 2014 updated by: UCB Pharma

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

654

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • RTP, North Carolina, United States, 27709
        • Schwarz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic neuropathy

Exclusion Criteria:

  • Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To investigate the efficacy of 200, 400, and 600mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.

Secondary Outcome Measures

Outcome Measure
To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, and quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0768

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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