NCT00350103

A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Using Two Different Titration Schemes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 551 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	SPM 929	* Pharmaceutical form: Immediate release film-coated tablets * Concentration: 50mg/ 100mg * Route of administration: Oral use
DRUG	Placebo	* Pharmaceutical form: Immediate release film-coated tablets * Route of administration: Oral use

Timeline

• Start date: 2006-06-30
• Primary completion: 2007-06-29
• Completion: 2007-06-29
• First posted: 2006-07-10
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

1 site across 1 country: Germany