NCT00485472

Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Osteoarthritis of the Knee

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.

Detailed description

LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe. The study has an adaptive 3-stage group sequential design. The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period. The last subject is expected to be enrolled in December 2007. The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	lacosamide	50 or 100mg tablet, 400mg daily, for 12 weeks
OTHER	Placebo	50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-11-01
• Completion: 2008-01-01
• First posted: 2007-06-13
• Last updated: 2017-08-28
• Results posted: 2009-09-22

Locations

26 sites across 7 countries: Czechia, Germany, Hungary, Poland, Romania, Sweden, United Kingdom