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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00235469
First received: October 6, 2005
Last updated: February 22, 2010
Last verified: February 2010
History of Changes

October 6, 2005
February 22, 2010
April 2004
June 2005   (final data collection date for primary outcome measure)
To investigate the efficacy of 200, 400, and 600 mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.
Not Provided
Complete list of historical versions of study NCT00235469 on ClinicalTrials.gov Archive Site
To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.
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A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety OF 200, 400, AND 600 mg/Day SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or 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 ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to 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), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetic Neuropathy
Drug: SPM 927
Not Provided
Wymer JP, Simpson J, Sen D, Bongardt S; Lacosamide SP742 Study Group. Efficacy and safety of lacosamide in diabetic neuropathic pain: an 18-week double-blind placebo-controlled trial of fixed-dose regimens. Clin J Pain. 2009 Jun;25(5):376-85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
496
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Painful distal diabetic neuropathy

Exclusion Criteria:

  • Must have an average pain intensity of ≥ 4 on an 11-point Likert scale
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00235469
SP742
Not Provided
Not Provided
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center UCB, Inc.
UCB, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP