Trial record 1 of 1 for:
NCT00485472
Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
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| ClinicalTrials.gov Identifier: NCT00485472 |
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Recruitment Status :
Terminated
(Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified.)
First Posted : June 13, 2007
Results First Posted : September 22, 2009
Last Update Posted : August 28, 2017
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Drug: lacosamide Other: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 194 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | March 2007 |
| Actual Primary Completion Date : | November 2007 |
| Actual Study Completion Date : | January 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Lacosamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lacosamide
lacosamide (LCM)
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Drug: lacosamide
50 or 100mg tablet, 400mg daily, for 12 weeks
Other Name: VIMPAT |
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Placebo Comparator: Placebo
Placebo
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Other: Placebo
50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide |
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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485472
Locations
| Czechia | |
| Kladno, Czechia | |
| Prague, Czechia | |
| 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) |
Additional Information:
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00485472 |
| Other Study ID Numbers: |
SP0905 2006-005048-97 ( EudraCT Number ) |
| First Posted: | June 13, 2007 Key Record Dates |
| Results First Posted: | September 22, 2009 |
| Last Update Posted: | August 28, 2017 |
| Last Verified: | July 2017 |
Keywords provided by UCB Pharma:
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Osteoarthritis lacosamide VIMPAT |
Additional relevant MeSH terms:
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Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Lacosamide Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |