Back to resultsA Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
Primary Purpose
Painful Diabetic Neuropathy
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
SPM 929
Sponsored by
About this trial
This is an interventional treatment trial for Painful Diabetic Neuropathy
Eligibility Criteria
Inclusion Criteria: Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II). 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
Sites / Locations
- SCHWARZ BIOSCIENCES GmbH
Outcomes
Primary Outcome Measures
To investigate the efficacy of LCM compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. Two titration schemes will be used; the first is a standard titration scheme such that the target dose of 400mg/day
Secondary Outcome Measures
To investigate the onset of action under treatment of LCM, the effect of LCM on subjects' perception of pain, sleep, activity, and quality of life, and to further investigate the safety of LCM
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00350103
Brief Title
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
Official Title
A Multicenter, Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy Using Two Different Titration Schemes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.
The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
537 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SPM 929
Primary Outcome Measure Information:
Title
To investigate the efficacy of LCM compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. Two titration schemes will be used; the first is a standard titration scheme such that the target dose of 400mg/day
Time Frame
8 days and 22 days
Secondary Outcome Measure Information:
Title
To investigate the onset of action under treatment of LCM, the effect of LCM on subjects' perception of pain, sleep, activity, and quality of life, and to further investigate the safety of LCM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
Facility Name
SCHWARZ BIOSCIENCES GmbH
City
Monheim
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
We'll reach out to this number within 24 hrs