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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005048-97 | EudraCT Number |
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Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | lacosamide (LCM) |
|
| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lacosamide | Drug | 50 or 100mg tablet, 400mg daily, for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain. | Baseline, end of 8 week Maintenance Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score. | 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. | Baseline, end of 8 week Maintenance Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kladno | Czechia | |||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Of the 194 enrolled subjects, 149 subjects have been randomized until trial termination. The Participants flow refers to the randomized population. Of the 149 randomized subjects, 148 subjects have been treated and are included in the safety population, 145 have been included in the ITT population (Full Analysis Set).
Trial utilized an adaptive 3-stage group sequential design. The Data Monitoring Committee had recommended to stop the trial after the first stage due to lack of efficacy. Results refer to the entire population randomized until discontinuation of study (including overrun).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Lacosamide (LCM) 400 mg/day |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | 50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide |
|
| Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score. |
The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness. |
| Baseline, end of 8 week Maintenance Period |
| Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score. | 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. | Baseline, end of 8 week Maintenance Period |
| Patient's Global Impression of Change From Baseline 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'. | at the end of 8 week Maintenance Period |
| 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). | 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. | Baseline, end of 8 week Maintenance Period |
| Amount of Rescue Medication Use During 8 Week Maintenance Period. | Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day. | during 8 week Maintenance Period |
| Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep. | 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). | Baseline, end of 8 week Maintenance Period |
| Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score). | 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. | Baseline, end of 8 week Maintenance Period |
| Prague |
| Czechia |
| Bad Hersfeld | Germany |
| Berlin | Germany |
| Hamburg | Germany |
| Leipzig | Germany |
| München | Germany |
| Debrecen | Hungary |
| Esztegom | Hungary |
| Győr | Hungary |
| Gyula | Hungary |
| Verseghy | Hungary |
| Veszprém | Hungary |
| Bialystok | Poland |
| Krakow | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Brăila | Romania |
| Lasi | Romania |
| Targoviste | Romania |
| Timișoara | Romania |
| Stockholm | Sweden |
| Morriston | United Kingdom |
| Newcastle | United Kingdom |
| Oxford | United Kingdom |
| Stanmore | United Kingdom |
| Entered Maintenance Phase |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Lacosamide (LCM) 400 mg/day |
| BG001 | Placebo | Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Last observation carried forward (LOCF) imputation method was applied in case of missing WOMAC assessment. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, end of 8 week Maintenance Period |
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| Secondary | Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score. | 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. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, end of 8 week Maintenance Period |
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| Secondary | Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score. | The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, end of 8 week Maintenance Period |
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| Secondary | Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score. | 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. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, end of 8 week Maintenance Period |
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| Secondary | Patient's Global Impression of Change From Baseline 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'. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing measurements of Patient's global impression of change from baseline were included. | Posted | Number | Participants | at the end of 8 week Maintenance Period |
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| Secondary | 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). | 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. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Dropouts due to lack of efficay were defined as non-responders. For dropouts due to any other reason LOCF was applied to the underlying WOMAC subscale scores. | Posted | Number | participants | Baseline, end of 8 week Maintenance Period |
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| Secondary | Amount of Rescue Medication Use During 8 Week Maintenance Period. | Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects who entered the Maintenance Phase were included. | Posted | Mean | Standard Deviation | tablets/day | during 8 week Maintenance Period |
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| Secondary | Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep. | 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). | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, end of 8 week Maintenance Period |
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| Secondary | Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score). | 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. | Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, end of 8 week Maintenance Period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lacosamide | Lacosamide (LCM) 400 mg/day | 4 | 72 | 16 | 72 | ||
| EG001 | Placebo | Placebo | 2 | 76 | 13 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Shock hypoglycaemic | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| >=65 years |
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| Male |
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| Czech Republic |
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| Germany |
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| Poland |
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| Romania |
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| Participants |
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