Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011181-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.
The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Add-on | Experimental | Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening. |
|
| Later Add-on | Experimental | Lacosamide added to 1 to 3 Antiepileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Oral Lacosamide: Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase | A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time. This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn. | From Week 7 (end of Week 6) to end of Week 18 |
Not provided
Not provided
Inclusion Criteria:
Group 1:
Group 2:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 103 | Irvine | California | United States | |||
| 123 |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Overall 461 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 456 subjects were included in the Safety Set.
An estimated 656 subjects were to be enrolled in the study at approximately 130 sites in the US, Europe, and the rest of the world.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | First Add-on | Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Rancho Mirage |
| California |
| United States |
| 156 | Clearwater | Florida | United States |
| 157 | Destin | Florida | United States |
| 140 | Hollywood | Florida | United States |
| 161 | Ocala | Florida | United States |
| 108 | Atlanta | Georgia | United States |
| 112 | Atlanta | Georgia | United States |
| 124 | Augusta | Georgia | United States |
| 115 | Macon | Georgia | United States |
| 118 | Rome | Georgia | United States |
| 128 | Flossmoor | Illinois | United States |
| 130 | Des Moines | Iowa | United States |
| 102 | Bowling Green | Kentucky | United States |
| 117 | Paducah | Kentucky | United States |
| 107 | Houma | Louisiana | United States |
| 145 | Ruston | Louisiana | United States |
| 101 | Annapolis | Maryland | United States |
| 162 | Waldorf | Maryland | United States |
| 153 | Boston | Massachusetts | United States |
| 136 | Pittsfield | Massachusetts | United States |
| 144 | Springfield | Massachusetts | United States |
| 151 | Kansas City | Missouri | United States |
| 114 | Paterson | New Jersey | United States |
| 109 | Brooklyn | New York | United States |
| 133 | Brooklyn | New York | United States |
| 127 | West Seneca | New York | United States |
| 158 | Charlotte | North Carolina | United States |
| 139 | Bismarck | North Dakota | United States |
| 134 | Akron | Ohio | United States |
| 150 | Canton | Ohio | United States |
| 141 | Tulsa | Oklahoma | United States |
| 121 | Indiana | Pennsylvania | United States |
| 120 | Columbia | South Carolina | United States |
| 149 | Orangeburg | South Carolina | United States |
| 152 | Spartanburg | South Carolina | United States |
| 148 | Austin | Texas | United States |
| 154 | Dallas | Texas | United States |
| 146 | Tomball | Texas | United States |
| 119 | Fredericksburg | Virginia | United States |
| 503 | Vienna | Austria |
| 703 | Blagoevrad | Bulgaria |
| 706 | Pleven | Bulgaria |
| 700 | Sofia | Bulgaria |
| 702 | Sofia | Bulgaria |
| 704 | Sofia | Bulgaria |
| 705 | Sofia | Bulgaria |
| 707 | Sofia | Bulgaria |
| 708 | Sofia | Bulgaria |
| 701 | Varna | Bulgaria |
| 736 | Hradec Králové | Czechia |
| 735 | Litoměřice | Czechia |
| 733 | Ostrava | Czechia |
| 732 | Ostrava-Hrabuvka | Czechia |
| 737 | Prague | Czechia |
| 734 | Trutnov | Czechia |
| 930 | Aarhus | Denmark |
| 400 | Helsinki | Finland |
| 402 | Oulu | Finland |
| 401 | Tampere | Finland |
| 610 | Strasbourg | France |
| 611 | Toulon | France |
| 521 | Athens | Greece |
| 520 | Thessaloniki | Greece |
| 552 | Faenza | Italy |
| 546 | Gallarate | Italy |
| 541 | Naples | Italy |
| 559 | Pietra Ligure | Italy |
| 557 | Prato | Italy |
| 540 | Roma | Italy |
| 549 | Roma | Italy |
| 542 | Taranto | Italy |
| 547 | Torino | Italy |
| 551 | Trieste | Italy |
| 180 | Aguascalientes | Mexico |
| 183 | Chihuahua City | Mexico |
| 185 | Chihuahua City | Mexico |
| 184 | Ciudad Juárez | Mexico |
| 189 | Guadalajara | Mexico |
| 181 | Mexico City | Mexico |
| 193 | Mexico City | Mexico |
| 195 | Mexico City | Mexico |
| 186 | Monterrey | Mexico |
| 187 | Monterrey | Mexico |
| 188 | Monterrey | Mexico |
| 182 | Polanco | Mexico |
| 815 | Bucharest | Romania |
| 810 | Cluj-Napoca | Romania |
| 814 | Oradea | Romania |
| 813 | Târgu Mureş | Romania |
| 830 | Kazan' | Russia |
| 831 | Kazan' | Russia |
| 834 | Moscow | Russia |
| 833 | Novosibirsk | Russia |
| 598 | Terrassa | Barcelona | Spain |
| 592 | AlmerÃa | Spain |
| 597 | Bajo Sevilla | Spain |
| 590 | Barcelona | Spain |
| 596 | Santiago de Compostela | Spain |
| 594 | Valencia | Spain |
| 599 | Valladolid | Spain |
| 892 | Lausanne | Switzerland |
| 713 | Adana | Turkey (Türkiye) |
| 714 | Ankara | Turkey (Türkiye) |
| 710 | Eskişehir | Turkey (Türkiye) |
| 711 | Istanbul | Turkey (Türkiye) |
| 719 | Istanbul | Turkey (Türkiye) |
| 717 | Izmir | Turkey (Türkiye) |
| 718 | Trabzon | Turkey (Türkiye) |
| FG001 | Later Add-on | Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Phase |
|
|
The Baseline Analysis Population refers to the Safety Set (SS) which includes all enrolled subjects who took at least one dose of study medication. 5 subjects at one site were excluded from the Safety Set due to significant study conduct deficiencies.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | First Add-on | Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
| BG001 | Later-Add-on | Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Median | Full Range | kilogram |
| |||||||||||||||
| Height | Median | Full Range | centimeter |
| |||||||||||||||
| BMI | Median | Full Range | kilogram per m^2 |
|
| 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 | The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase | A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time. This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn. | The Analysis Population refers to the Completer Set (CS) which includes all subjects who were enrolled, received at least one dose of Lacosamide and completed the first 12 weeks of the Maintenance Phase. | Posted | Number | percentage of subjects | From Week 7 (end of Week 6) to end of Week 18 |
|
|
|
Treatment Emergent Adverse Events were collected from Screening (Week -1) until the end of the study ( up to Week 33).
Treatment Emergent Adverse Events started on/after the date of first dose and within 30 days of the date of last dose.
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 | First Add-on | Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week | 8 | 96 | 53 | 96 | ||
| EG001 | Later Add-on | Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week | 19 | 360 | 212 | 360 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| C476828 | 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)- |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Patient moving out of area |
|
| Non compliance to study procedures |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|