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| Sponsored by: |
UCB |
|---|---|
| Information provided by: | UCB |
| ClinicalTrials.gov Identifier: | NCT00485472 |
Purpose
Lacosamide (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 purpose of this trial is to evaluate the effectiveness, safety and tolerability of LCM taken orally twice a day for about 3 months.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: lacosamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Study Start Date: | March 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Based on the outcome of a 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.
The Company remains committed to the program and is going to undertake a thorough analysis of the full clinical data set.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |
| Prague, Czech Republic | |
| Kladno, Czech Republic | |
| Germany | |
| Hamburg, Germany | |
| München, Germany | |
| Leipzig, Germany | |
| Berlin, Germany | |
| Bad Hersfeld, Germany | |
| Hungary | |
| Gyula, Hungary | |
| Esztegom, Hungary | |
| Debrecen, Hungary | |
| Verseghy, Hungary | |
| Veszprem, Hungary | |
| Gyor, Hungary | |
| Poland | |
| Krakow, Poland | |
| Bialystok, Poland | |
| Warszawa, Poland | |
| Torun, Poland | |
| Romania | |
| Braila, Romania | |
| Timisoara, Romania | |
| Targoviste, Romania | |
| Lasi, Romania | |
| Sweden | |
| Stockholm, Sweden | |
| United Kingdom | |
| Stanmore, United Kingdom | |
| Newcastle, United Kingdom | |
| Oxford, United Kingdom | |
| Morriston, United Kingdom | |
| Study Director: | Tony Daniels | Schwarz Biosciences Inc. |
More Information
| Study ID Numbers: | SP905 |
| Study First Received: | June 12, 2007 |
| Last Updated: | April 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00485472 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
