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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005440-25 | EudraCT Number |
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This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Lacosamide tablets for dosing 100 -800 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | 50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study | Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study. | From Visit 1 to End of Study (approximately 2 years) |
| Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study | Duration of total Lacosamide Monotherapy From Visit 1 to End of Study. | From Visit 1 to End of Study (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study | A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). |
Not provided
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 |
|---|---|---|---|---|---|---|
| 048 | Alabaster | Alabama | United States | |||
| 010 |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Participant Flow refers to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
This Multicenter, Open-Label Study started to enroll Subjects in February 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Lacosamide tablets for dosing 100 -800 mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| From Visit 1 to End of Study (approximately 2 years) |
| Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study | From Visit 1 to End of Study (approximately 2 years) |
| Birmingham |
| Alabama |
| United States |
| 042 | Northport | Alabama | United States |
| 009 | Phoenix | Arizona | United States |
| 014 | Phoenix | Arizona | United States |
| 151 | Phoenix | Arizona | United States |
| 103 | Tucson | Arizona | United States |
| 102 | Jonesboro | Arkansas | United States |
| 007 | Little Rock | Arkansas | United States |
| 086 | Little Rock | Arkansas | United States |
| 120 | La Habra | California | United States |
| 059 | Los Angeles | California | United States |
| 021 | Santa Monica | California | United States |
| 107 | Torrance | California | United States |
| 060 | Aurora | Colorado | United States |
| 025 | Fairfield | Connecticut | United States |
| 094 | Doral | Florida | United States |
| 108 | Gainesville | Florida | United States |
| 123 | Miami | Florida | United States |
| 132 | Miami | Florida | United States |
| 077 | Orlando | Florida | United States |
| 049 | Panama City | Florida | United States |
| 129 | Port Charlotte | Florida | United States |
| 050 | Sarasota | Florida | United States |
| 004 | Tallahassee | Florida | United States |
| 079 | Atlanta | Georgia | United States |
| 058 | Boise | Idaho | United States |
| 131 | Hines | Illinois | United States |
| 146 | Peoria | Illinois | United States |
| 011 | Springfield | Illinois | United States |
| 078 | Indianapolis | Indiana | United States |
| 073 | Ames | Iowa | United States |
| 124 | Manhattan | Kansas | United States |
| 023 | Wichita | Kansas | United States |
| 160 | Wichita | Kansas | United States |
| 164 | Lexington | Kentucky | United States |
| 062 | Louisville | Kentucky | United States |
| 029 | Scarborough | Maine | United States |
| 020 | Baltimore | Maryland | United States |
| 034 | Baltimore | Maryland | United States |
| 065 | Pikesville | Maryland | United States |
| 137 | Waldorf | Maryland | United States |
| 041 | Detroit | Michigan | United States |
| 030 | Golden Valley | Minnesota | United States |
| 071 | Hattiesburg | Mississippi | United States |
| 031 | Chesterfield | Missouri | United States |
| 066 | St Louis | Missouri | United States |
| 017 | Lebanon | New Hampshire | United States |
| 067 | Voorhees Township | New Jersey | United States |
| 036 | Albany | New York | United States |
| 083 | Buffalo | New York | United States |
| 069 | Cedarhurst | New York | United States |
| 027 | New York | New York | United States |
| 122 | New York | New York | United States |
| 003 | Asheville | North Carolina | United States |
| 063 | Durham | North Carolina | United States |
| 117 | Wilmington | North Carolina | United States |
| 015 | Cleveland | Ohio | United States |
| 061 | Columbus | Ohio | United States |
| 002 | Toledo | Ohio | United States |
| 147 | Oklahoma City | Oklahoma | United States |
| 100 | Greensburg | Pennsylvania | United States |
| 032 | Philadelphia | Pennsylvania | United States |
| 024 | Beaufort | South Carolina | United States |
| 114 | Chattanooga | Tennessee | United States |
| 001 | Nashville | Tennessee | United States |
| 138 | Austin | Texas | United States |
| 022 | Dallas | Texas | United States |
| 046 | El Paso | Texas | United States |
| 051 | Houston | Texas | United States |
| 053 | Houston | Texas | United States |
| 098 | San Antonio | Texas | United States |
| 136 | Layton | Utah | United States |
| 161 | Alexandria | Virginia | United States |
| 016 | Charlottesville | Virginia | United States |
| 074 | Renton | Washington | United States |
| 080 | Madison | Wisconsin | United States |
| 421 | Capmerdown | New South Wales | Australia |
| 425 | Chatswood | New South Wales | Australia |
| 423 | Herston | Queensland | Australia |
| 420 | Adelaide | South Australia | Australia |
| 427 | Parkville | Victoria | Australia |
| 140 | Halifax | Nova Scotia | Canada |
| 116 | Hamilton | Ontario | Canada |
| 093 | London | Ontario | Canada |
| 091 | Greenfield Park | Quebec | Canada |
| 110 | Montreal | Quebec | Canada |
| 113 | Montreal | Quebec | Canada |
| 127 | Calgary | Canada |
| 223 | Aarhus | Denmark |
| 461 | Mainz | Germany |
| 443 | Ferrara | Italy |
| 445 | Reggio Calabria | Italy |
| 447 | Torrette Di Ancona | Italy |
| 284 | Częstochowa | Poland |
| 286 | Gdansk | Poland |
| 282 | Gdynia | Poland |
| 280 | Krakow | Poland |
| 290 | Lublin | Poland |
| 289 | Szczecin | Poland |
| 281 | Warsaw | Poland |
| 287 | Warsaw | Poland |
| 324 | Santa Cruz de Tenerife | Spain |
| 360 | Blackpool | United Kingdom |
| 367 | Cornwall | United Kingdom |
| 364 | London | United Kingdom |
| 369 | London | United Kingdom |
| 363 | Middlesbrough | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Lacosamide tablets for dosing 100 -800 mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study | Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study. | All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication. | Posted | Number | Participants | From Visit 1 to End of Study (approximately 2 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study | Duration of total Lacosamide Monotherapy From Visit 1 to End of Study. | All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication. | Posted | Mean | Standard Deviation | days | From Visit 1 to End of Study (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study | A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). | All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication. | Posted | Number | Participants | From Visit 1 to End of Study (approximately 2 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study | All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication. | Posted | Number | Participants | From Visit 1 to End of Study (approximately 2 years) |
|
|
Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Not provided
| 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 tablets for dosing 100 -800 mg/day | 56 | 322 | 238 | 322 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Sudden unexplained death in epilepsy | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Electroencephalogram | Investigations | MedDRA16.1 | Non-systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA16.1 | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA16.1 | Non-systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA16.1 | Non-systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA16.1 | Non-systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA16.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Postictal state | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Complicated migraine | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Postictal psychosis | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA16.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA16.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| Asian |
|
| Other |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|