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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002461-37 | EudraCT Number |
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The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period. Maximum duration of study drug administration is approximately 23 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention at the End of the 21-week Treatment Period | Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness. | Duration of the Treatment Period (21 Weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | 877-822-9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 110 | Huntsville | Alabama | United States | |||
| 004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27714769 | Result | Baulac M, Byrnes W, Williams P, Borghs S, Webster E, De Backer M, Dedeken P. Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy. Acta Neurol Scand. 2017 Apr;135(4):434-441. doi: 10.1111/ane.12691. Epub 2016 Oct 6. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The participant flow consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
The recruitment for the SP0980 study began in December 2011. It concluded in January 2014. This was a multicenter study with subjects enrolled by 30 sites across North America, 12 in Western Europe, 10 in Eastern Europe, and 2 in Oceania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED). Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period. Maximum duration of study drug administration is approximately 23 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phoenix |
| Arizona |
| United States |
| 001 | Fresno | California | United States |
| 008 | Orange | California | United States |
| 030 | Oxnard | California | United States |
| 108 | Sacramento | California | United States |
| 025 | Bradenton | Florida | United States |
| 015 | Ocala | Florida | United States |
| 049 | Panama City | Florida | United States |
| 114 | Port Charlotte | Florida | United States |
| 012 | Sarasota | Florida | United States |
| 014 | Tampa | Florida | United States |
| 003 | Wellington | Florida | United States |
| 123 | Louisville | Kentucky | United States |
| 006 | Hammond | Louisiana | United States |
| 112 | Waldorf | Maryland | United States |
| 129 | Golden Valley | Minnesota | United States |
| 023 | Springfield | Missouri | United States |
| 088 | Missoula | Montana | United States |
| 020 | Camden | New Jersey | United States |
| 131 | Greensboro | North Carolina | United States |
| 002 | Akron | Ohio | United States |
| 027 | Canton | Ohio | United States |
| 022 | Columbus | Ohio | United States |
| 005 | Dayton | Ohio | United States |
| 013 | Oklahoma City | Oklahoma | United States |
| 028 | Lubbock | Texas | United States |
| 017 | Salt Lake City | Utah | United States |
| 139 | Madison | Wisconsin | United States |
| 024 | Milwaukee | Wisconsin | United States |
| 075 | Chatswood | Australia |
| 079 | Parkville | Australia |
| 036 | Rousse | Bulgaria |
| 037 | Sofia | Bulgaria |
| 080 | Sofia | Bulgaria |
| 081 | Sofia | Bulgaria |
| 082 | Sofia | Bulgaria |
| 059 | Aarhus | Denmark |
| 087 | Copenhagen | Denmark |
| 042 | Angers | France |
| 040 | Limoges | France |
| 046 | Paris | France |
| 065 | Bielefeld | Germany |
| 066 | Hamburg | Germany |
| 068 | Tübingen | Germany |
| 096 | Bucharest | Romania |
| 099 | Bucharest | Romania |
| 097 | Lasi | Romania |
| 038 | Târgu Mureş | Romania |
| 095 | Târgu Mureş | Romania |
| 051 | Manresa | Spain |
| 053 | Oviedo | Spain |
| 050 | Seville | Spain |
| 102 | Gothenburg | Sweden |
| COMPLETED |
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| NOT COMPLETED |
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The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED). Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period. Maximum duration of study drug administration is approximately 23 weeks. |
| 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 |
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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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| Weight | Mean | Standard Deviation | kilograms |
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| Height | Mean | Standard Deviation | centimeters |
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| BMI | Mean | Standard Deviation | kilogram/ square meter |
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| Racial Group | Number | participants |
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| Ethnicity | 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 | Retention at the End of the 21-week Treatment Period | Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness. | The primary analysis consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide. | Posted | Number | percentage of participants | Duration of the Treatment Period (21 Weeks) |
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Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
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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 will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED). Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period. Maximum duration of study drug administration is approximately 23 weeks. | 8 | 120 | 52 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vulvovaginitis Trichomonal | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Migraine | 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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| Mental Status Changes | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Asthma | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fatigue | General 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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| Convulsion | Nervous system 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 | |
|---|---|---|---|---|
| Study Director | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
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| Black |
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| Native Hawaiian or other Pacific Islander |
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| White |
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| Other/Mixed |
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