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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004384-21 | EudraCT Number |
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The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study [NCT00655551] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lacosamide | Drug | Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) | An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | 2 years |
| Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) | An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | 2 years |
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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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baltimore |
| Maryland |
| United States |
| Chesterfield | Missouri | United States |
| Columbus | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Dallas | Texas | United States |
| Charlottesville | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
| 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 |
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| 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 | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) | An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis | Posted | Number | subjects | 2 years |
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| Primary | Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) | An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis | Posted | Number | subjects | 2 years |
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2 years
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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 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) | 10 | 97 | 88 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Drug interaction | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Giardiasis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Homicidal ideation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Paranoia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Depression suicidal | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Diplopia | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.1) | 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 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 results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB, Inc | +1 877 822 9493 |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| 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 |
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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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