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

This study has been terminated.
(Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified.)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00485472
First received: June 12, 2007
Last updated: August 27, 2014
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: lacosamide
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline, end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.


Secondary Outcome Measures:
  • Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score. [ Time Frame: Baseline, end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    The WOMAC physical function subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of difficulty in performing daily activities.

  • Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score. [ Time Frame: Baseline, end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness.

  • Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score. [ Time Frame: Baseline, end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    The WOMAC total score is the sum of the normalized subscale scores for pain, stiffness, and physical function and ranges from 0 to 300, high values describe high grade of impact.

  • Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period. [ Time Frame: at the end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    Patient's global impression of change from baseline is a score that ranges from 'very much worse' to 'very much improved'.

  • 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). [ Time Frame: Baseline, end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    Improvement = reduction of >= 20% and >= 10 mm in both WOMAC pain and physical function subscale. Those who met the criteria in either of the subscales had improved if response to Patient's Global Impression of change from baseline was at least 'mildly improved'. High improvement = reduction of >= 50% and >= 20 mm in either of the subscales. Response = either high improvement or improvement.

  • Amount of Rescue Medication Use During 8 Week Maintenance Period. [ Time Frame: during 8 week Maintenance Period ] [ Designated as safety issue: No ]
    Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day.

  • Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep. [ Time Frame: Baseline, end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    Pain interference with sleep refers to patient's last evening prior to the visit and was assessed using a 100mm visual analog scale (VAS). The VAS ranges from 0 (did not interfere) to 100 (completely interfered).

  • Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score). [ Time Frame: Baseline, end of 8 week Maintenance Period ] [ Designated as safety issue: No ]
    Total Mood Disturbance score sums up over the domain scores regarding Tension-anxiety, Depression-ejection, Anger-hostility, Vigor-activity (was subtracted), Fatigue-inertia, Confusion-bewilderment. Domain scores were derived as sum of the respective items and range from 0 to 20. With exception of Vigor-activity high values describe bad mood.


Enrollment: 194
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
lacosamide (LCM)
Drug: lacosamide
50 or 100mg tablet, 400mg daily, for 12 weeks
Other Name: VIMPAT
Placebo Comparator: Placebo
Placebo
Other: Placebo
50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide

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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485472

Locations
Czech Republic
Kladno, Czech Republic
Prague, Czech Republic
Germany
Bad Hersfeld, Germany
Berlin, Germany
Hamburg, Germany
Leipzig, Germany
München, Germany
Hungary
Debrecen, Hungary
Esztegom, Hungary
Gyor, Hungary
Gyula, Hungary
Verseghy, Hungary
Veszprem, Hungary
Poland
Bialystok, Poland
Krakow, Poland
Torun, Poland
Warszawa, Poland
Romania
Braila, Romania
Lasi, Romania
Targoviste, Romania
Timisoara, Romania
Sweden
Stockholm, Sweden
United Kingdom
Morriston, United Kingdom
Newcastle, United Kingdom
Oxford, United Kingdom
Stanmore, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00485472     History of Changes
Other Study ID Numbers: SP905, 2006-005048-97
Study First Received: June 12, 2007
Results First Received: August 12, 2009
Last Updated: August 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Sweden: Medical Products Agency
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health

Keywords provided by UCB Pharma:
Osteoarthritis
lacosamide
VIMPAT

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014