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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019268-35 | EudraCT Number |
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To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.
Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Flexible dosing between 200mg/day and 400mg/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study | Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. | During the study ( up to 24 - 28 weeks) |
| Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study | Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. | During the study (up to 24 - 28 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period | The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase. | End of Treatment Period (24-week) |
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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 |
|---|---|---|---|---|---|---|
| Amiens | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28597842 | Result | Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1;19(2):186-194. doi: 10.1684/epd.2017.0907. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The study comprises a 12-week Titration Phase and a 12-week Maintenance Phase; both phases together are regarded as the 24-week Treatment Period.
Participant Flow and Baseline Characteristics refer to the Safety Set (SS). The SS includes all subjects that received at least one dose of study medication.
This is a 24-week study, which enrolled 100 patients at 44 sites in France.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Flexible dosing between 200 mg/day and 400 mg/day Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Aubenas |
| France |
| Auxerre | France |
| Bordeaux | France |
| Brest | France |
| Caen | France |
| Carpentras | France |
| Châteaubriand | France |
| Colmar | France |
| Créteil | France |
| Gap | France |
| Gonesse | France |
| La Rochelle | France |
| Laval | France |
| Limoges | France |
| Marseille | France |
| Montluçon | France |
| Nice | France |
| Nîmes | France |
| Paris | France |
| Perpignan | France |
| Poitiers | France |
| Pringy | France |
| Rennes | France |
| Rouen | France |
| Saint Aubin Sur Cie | France |
| Saint Julien En Gengvois | France |
| Saint-Brieuc | France |
| St-Malo | France |
| Toulouse | France |
| Vienne | France |
| Villeurbanne | France |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Flexible dosing between 200mg/day and 400mg/day Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks |
| 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 |
| ||||||||||||||||||||
| 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 Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study | Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. | Safety Set | Posted | Number | subjects | During the study ( up to 24 - 28 weeks) |
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| Primary | Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study | Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. | Safety Set | Posted | Number | subjects | During the study (up to 24 - 28 weeks) |
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| Secondary | Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period | The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase. | Safety Set | Posted | Number | percentage of subjects | End of Treatment Period (24-week) |
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During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
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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 | Flexible dosing between 200mg/day and 400mg/day Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks | 3 | 100 | 49 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Coma | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Gait disturbance | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
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| 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 |
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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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