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

UCB

Status and phase

Terminated

Phase 2

Conditions

Osteoarthritis

Treatments

Drug: lacosamide

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485472

2006-005048-97 (EudraCT Number)

SP0905

Details and patient eligibility

About

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.

Full 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.

Enrollment

194 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
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).

Exclusion criteria

Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial