Conditions: Painful Diabetic Neuropathy
Keywords: Painful Diabetic Neuropathy Lacosamide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 551
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100 mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase. arm 2: Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase. arm 3: Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase

Interventions: intervention 1: SPM 929 intervention 2: Placebo
Intervention descriptions: intervention 1: * Pharmaceutical form: Immediate release film-coated tablets
* Concentration: 50mg/ 100mg
* Route of administration: Oral use intervention 2: * Pharmaceutical form: Immediate release film-coated tablets
* Route of administration: Oral use

Protocol document: