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

• Conditions: Osteoarthritis of the knee; MedDRA version: 8.1Level: LLTClassification code 10031165Term: Osteoarthritis knee

• Registration Number: EUCTR2006-005048-97-GB
• Lead Sponsor: SCHWARZ BIOSCIENCES GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Subjects must fulfill the following inclusion criteria:
1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
2. Subject is willing and able to comply with all trial requirements.
3. Subject is male or female and between 40 and 75 years of age.
4. Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
5. Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or
paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are not permitted to enroll in the trial if any of the following criteria are met:
1. Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.
2. Subject has participated in another trial of an investigational drug (or a physical stability treatment) within the last 30 days or is currently participating in another trial of an investigational drug (or physical stability treatment).
3. Subject has a history of chronic alcohol or drug abuse or dependence according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria (see Section 15.3, Criteria for substance abuse and substance dependence) within the last 2 years.
4. Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject’s ability to participate in this trial or could confound the analysis of efficacy.
5. Subject is taking analgesics (including herbal remedies) other than NSAIDs, COX-2
NSAIDs, and/or paracetamol/acetaminophen. Refer to Section 4.6, Concomitant
medications/treatments, for details on prohibited medications prior to Visit 1.
6. Subject is not able or willing to discontinue NSAIDs, COX-2 NSAIDs, and/or
paracetamol/acetaminophen during the course of the trial as directed by the protocol.
7. Subject plans to begin or stop treatment with glucosamine and/or chondrotin during the trial. Refer to Section 4.6, Concomitant medications/treatments, for details.
8. Subject plans to begin or stop chronic physical therapy regimen during the trial. Refer to Section 4.6, Concomitant medications/treatments, for details.
9. Subject has growth disturbances or crystal-induced arthropathies.
10. Subject has musculoskeletal disorders not attributed to osteoarthritis.
11. Subject has a history and/or diagnosis of a non-osteoarthritis pain syndrome, rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, septic arthritis, erosive inflammatory osteoarthritis or joint disease, or diffuse idiopathic skeletal hyperostosis.
12. Subject has other chronic conditions that cause significant pain unless subject can clearly distinguish this pain from that in the index knee. These cases should be discussed with the medical monitor.
13. Subject has a rating of =80mm in any element of the WOMAC VAS pain subscale at Visit 1.
14. Subject has had partial or complete joint replacement of the index knee or expects to schedule a surgical procedure including a knee replacement of the index knee during the course of the trial.
15. Subject has used a custom orthotic for less than 3 months.
16. Subject is using a walker or cane.
17. Subject has had active (redness, swelling, fever, etc) gout or pseudo-gout within 6 months prior to Visit 1.
18. Subject has Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondromatosis, heritable disorders (eg, hypermobility), or collagen gene mutations.
19. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin levels =2 times the upper limit of normal (ULN) or has alkaline phosphatase levels =3 times ULN at Visit 1.
20. Subject has impaired renal function, ie, creatinine clearance (CLcr) is lower than 50mL/min at Visit 1.
21. Subject has other laboratory values that are outside the normal range at Visit 1 and judged by the investigator as clini

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to assess efficacy of LCM 400mg/day compared with placebo in reducing pain in subjects with osteoarthritis of the knee. ;Secondary Objective: Secondary objectives are to investigate the effect of LCM on physical functioning and stiffness, patient’s global impression of change in pain, sleep interference, and mood as well as the safety and tolerability of LCM. ;Primary end point(s): The primary efficacy variable for this trial is the within-subject change in the WOMAC pain subscale score (using the VAS version) from Baseline to the end of the Maintenance Period.