A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy
Status:
Completed
Trial end date:
2005-01-01
Target enrollment:
Participant gender:
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.