A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy
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
1 other identifier
interventional
357
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2003
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 11, 2005
CompletedFirst Posted
Study publicly available on registry
October 13, 2005
CompletedSeptember 22, 2014
April 1, 2010
1.1 years
October 11, 2005
September 19, 2014
Conditions
Keywords
Outcome Measures
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.
Interventions
Eligibility Criteria
You may qualify if:
- Painful distal diabetic neuropathy
You may not qualify if:
- Symptoms of painful distal diabetic neuropathy for less than six months or greater than 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (1)
Schwarz
Monheim, Germany
Related Publications (1)
Ziegler D, Hidvegi T, Gurieva I, Bongardt S, Freynhagen R, Sen D, Sommerville K; Lacosamide SP743 Study Group. Efficacy and safety of lacosamide in painful diabetic neuropathy. Diabetes Care. 2010 Apr;33(4):839-41. doi: 10.2337/dc09-1578. Epub 2010 Jan 12.
PMID: 20067958RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 11, 2005
First Posted
October 13, 2005
Study Start
December 1, 2003
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
September 22, 2014
Record last verified: 2010-04