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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004398-18 | EudraCT Number |
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The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Up to 800 mg/day lacosamide (flexible dosing) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lacosamide | Drug | 50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | During the Treatment Period (Maximum 6 years) |
| Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | During the Treatment Period (Maximum 6 years) |
| Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) | Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | During the Treatment Period (Maximum 6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) | Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency. | Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years) |
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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22372628 | Result | Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Up to 800 mg/day lacosamide (flexible dosing) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) |
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. |
| Treatment Period (Maximum 6 years) |
| Mobile |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Little Rock | Arkansas | United States |
| Los Angeles | California | United States |
| San Francisco | California | United States |
| Englewood | Colorado | United States |
| Fairfield | Connecticut | United States |
| Bradenton | Florida | United States |
| Jacksonville | Florida | United States |
| Maitland | Florida | United States |
| St. Petersburg | Florida | United States |
| Tallahassee | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Springfield | Illinois | United States |
| Indianapolis | Indiana | United States |
| Wichita | Kansas | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Baltimore | Maryland | United States |
| Bethesda | Maryland | United States |
| Boston | Massachusetts | United States |
| Golden Valley | Minnesota | United States |
| Saint Cloud | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Chesterfield | Missouri | United States |
| Somerset | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Syracuse | New York | United States |
| Asheville | North Carolina | United States |
| Durham | North Carolina | United States |
| Greenville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Medford | Oregon | United States |
| Hershey | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Beaufort | South Carolina | United States |
| Charleston | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Charlottesville | Virginia | United States |
| Newport News | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Morgantown | West Virginia | United States |
| Marshfield | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Up to 800 mg/day lacosamide (flexible dosing) |
| 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 |
| ||||||||||||||||||||
| Region of Enrollment | 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 | Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated. | Posted | Number | subjects | During the Treatment Period (Maximum 6 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated. | Posted | Number | subjects | During the Treatment Period (Maximum 6 years) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) | Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated. | Posted | Number | subjects | During the Treatment Period (Maximum 6 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) | Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency. | Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study. | Posted | Median | Full Range | percentage change | Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) | At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. | Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study. | Posted | Number | percentage of subjects | Treatment Period (Maximum 6 years) |
|
|
Maximum of 6 years
Not provided
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 | Up to 800 mg/day lacosamide (flexible dosing) | 71 | 308 | 265 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Chronic hepatitis | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Enterobacter pneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Testis cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
| |
| Status epilepticus | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sleep attacks | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Angioneurotic oedema | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vagal nerve stimulator implantation | Surgical and medical procedures | MedDRA (9.1) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastrooesophagitis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and 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 the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 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 |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
|
|
|
|