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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004375-23 | EudraCT Number |
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The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) | |
| Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) |
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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 |
|---|---|---|---|---|---|---|
| 603 | Phoenix | Arizona | United States | |||
| 602 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28086164 | Result | Wechsler RT, Yates SL, Messenheimer J, Leroy R, Beller C, Doty P. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res. 2017 Feb;130:13-20. doi: 10.1016/j.eplepsyres.2016.12.015. Epub 2016 Dec 29. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS).
The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Little Rock |
| Arkansas |
| United States |
| 628 | Aurora | Colorado | United States |
| 613 | Atlanta | Georgia | United States |
| 617 | Boise | Idaho | United States |
| 614 | Fort Wayne | Indiana | United States |
| 605 | Lexington | Kentucky | United States |
| 616 | Louisville | Kentucky | United States |
| 619 | Scarborough | Maine | United States |
| 609 | Bethesda | Maryland | United States |
| 615 | Chesterfield | Missouri | United States |
| 607 | New York | New York | United States |
| 620 | Columbus | Ohio | United States |
| 608 | Charleston | South Carolina | United States |
| 601 | Nashville | Tennessee | United States |
| 612 | Dallas | Texas | United States |
| 610 | Norfolk | Virginia | United States |
| 623 | Renton | Washington | United States |
| 624 | Madison | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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Baseline measurements consist of the Safety Set (SS).
The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. |
| 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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| Weight | Mean | Standard Deviation | Kilograms |
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| Height | Mean | Standard Deviation | Centimeters |
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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 Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis. The SS consists of all subjects that were dosed at least once with Lacosamide (LCM). | Posted | Number | participants | From Visit 1 to the end of study (Approximately 61 weeks) |
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| Primary | Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis. The SS consists of all subjects that were dosed at least once with Lacosamide (LCM). | Posted | Number | participants | From Visit 1 to the end of study (Approximately 61 weeks) |
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Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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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 was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. | 3 | 39 | 35 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMONIA | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| CONVULSION | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| ABNORMAL BEHAVIOUR | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PALPITATIONS | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
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| DIPLOPIA | Eye 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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| FATIGUE | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| GAIT DISTURBANCE | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| SEASONAL ALLERGY | Immune system 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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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| TOOTH ABSCESS | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| JOINT SPRAIN | Injury, poisoning and procedural complications | 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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| EXCORIATION | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| SKIN LACERATION | 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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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| ARTERIAL BRUIT | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| DIZZINESS | 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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| TREMOR | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| POSTICTAL STATE | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| ANXIETY | 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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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| RESPIRATORY DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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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 |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| C562694 | Epilepsy, Idiopathic Generalized |
| 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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