Status:
COMPLETED
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
Lead Sponsor:
UCB Pharma
Collaborating Sponsors:
SCHWARZ BIOSCIENCES GmbH - Part of UCB Group
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2007
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00350103
Start Date
June 30 2006
End Date
June 29 2007
Last Update
March 22 2024
Active Locations (1)
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1
Monheim, Germany