Clinical trial NCT00485472: Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
lacosamide
VIMPAT
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 194
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period
timeFrame: Baseline, end of 8 week Maintenance Period
Secondary outcomes:
measure: Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.
timeFrame: Baseline, end of 8 week Maintenance Period
measure: Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.
timeFrame: Baseline, end of 8 week Maintenance Period
measure: Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.
timeFrame: Baseline, end of 8 week Maintenance Period
measure: Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.
timeFrame: at the end of 8 week Maintenance Period
measure: Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).
timeFrame: Baseline, end of 8 week Maintenance Period
measure: Amount of Rescue Medication Use During 8 Week Maintenance Period.
timeFrame: during 8 week Maintenance Period
measure: Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep.
timeFrame: Baseline, end of 8 week Maintenance Period
measure: Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).
timeFrame: Baseline, end of 8 week Maintenance Period
Other outcomes:
Locations:
city: Kladno
country: Czechia
city: Prague
country: Czechia
city: Bad Hersfeld
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Debrecen
country: Hungary
city: Esztegom
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Verseghy
country: Hungary
city: Veszprem
country: Hungary
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Braila
country: Romania
city: Lasi
country: Romania
city: Targoviste
country: Romania
city: Timisoara
country: Romania
city: Stockholm
country: Sweden
city: Morriston
country: United Kingdom
city: Newcastle
country: United Kingdom
city: Oxford
country: United Kingdom
city: Stanmore
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: