Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
NCT ID: NCT00955357
Last Updated: 2018-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
461 participants
INTERVENTIONAL
2009-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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First Add-on
Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug \[AED\] polytherapy) and epilepsy diagnosis \< or = 24 months at Screening.
Lacosamide
Oral Lacosamide:
Subjects Titration Phase (6 Weeks):
Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks):
200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks):
50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Later Add-on
Lacosamide added to 1 to 3 Antiepileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis \> or = 5 years at Screening.
Lacosamide
Oral Lacosamide:
Subjects Titration Phase (6 Weeks):
Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks):
200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks):
50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Interventions
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Lacosamide
Oral Lacosamide:
Subjects Titration Phase (6 Weeks):
Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks):
200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks):
50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
* Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
* Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
* The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures
Group 2:
* Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
* Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
* Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
* The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days
Exclusion Criteria
* History of seizure disorder characterized primarily by isolated auras
* History of primary generalized seizures
* History of status epilepticus within last 12-months
* History of cluster seizures during the 12 week period prior to Visit 1
* Nonepileptic events, including pseudoseizures that could be confused with seizure
* Lifetime history of suicide attempt or suicidal ideation in the past 6 months
* Hypersensitivity to any component of Lacosamide
* History of drug or alcohol abuse
* History of an acute or subacutely progressive Central Nervous System (CNS) disease
* Undergone cranial surgery within the last year prior to study entry
* Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
* Prior or concomitant Vigabatrin use
17 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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103
Irvine, California, United States
123
Rancho Mirage, California, United States
156
Clearwater, Florida, United States
157
Destin, Florida, United States
140
Hollywood, Florida, United States
161
Ocala, Florida, United States
108
Atlanta, Georgia, United States
112
Atlanta, Georgia, United States
124
Augusta, Georgia, United States
115
Macon, Georgia, United States
118
Rome, Georgia, United States
128
Flossmoor, Illinois, United States
130
Des Moines, Iowa, United States
102
Bowling Green, Kentucky, United States
117
Paducah, Kentucky, United States
107
Houma, Louisiana, United States
145
Ruston, Louisiana, United States
101
Annapolis, Maryland, United States
162
Waldorf, Maryland, United States
153
Boston, Massachusetts, United States
136
Pittsfield, Massachusetts, United States
144
Springfield, Massachusetts, United States
151
Kansas City, Missouri, United States
114
Paterson, New Jersey, United States
109
Brooklyn, New York, United States
133
Brooklyn, New York, United States
127
West Seneca, New York, United States
158
Charlotte, North Carolina, United States
139
Bismarck, North Dakota, United States
134
Akron, Ohio, United States
150
Canton, Ohio, United States
141
Tulsa, Oklahoma, United States
121
Indiana, Pennsylvania, United States
120
Columbia, South Carolina, United States
149
Orangeburg, South Carolina, United States
152
Spartanburg, South Carolina, United States
148
Austin, Texas, United States
154
Dallas, Texas, United States
146
Tomball, Texas, United States
119
Fredericksburg, Virginia, United States
503
Vienna, , Austria
703
Blagoevrad, , Bulgaria
706
Pleven, , Bulgaria
700
Sofia, , Bulgaria
702
Sofia, , Bulgaria
704
Sofia, , Bulgaria
705
Sofia, , Bulgaria
707
Sofia, , Bulgaria
708
Sofia, , Bulgaria
701
Varna, , Bulgaria
736
Hradec Králové, , Czechia
735
Litoměřice, , Czechia
733
Ostrava, , Czechia
732
Ostrava-Hrabuvka, , Czechia
737
Prague, , Czechia
734
Trutnov, , Czechia
930
Aarhus, , Denmark
400
Helsinki, , Finland
402
Oulu, , Finland
401
Tampere, , Finland
610
Strasbourg, , France
611
Toulon, , France
521
Athens, , Greece
520
Thessaloniki, , Greece
552
Faenza, , Italy
546
Gallarate, , Italy
541
Napoli, , Italy
559
Pietra Ligure, , Italy
557
Prato, , Italy
540
Roma, , Italy
549
Roma, , Italy
542
Taranto, , Italy
547
Torino, , Italy
551
Trieste, , Italy
180
Aguascalientes, , Mexico
183
Chihuahua City, , Mexico
185
Chihuahua City, , Mexico
184
Ciudad Juárez, , Mexico
189
Guadalajara, , Mexico
181
Mexico City, , Mexico
193
Mexico City, , Mexico
195
Mexico City, , Mexico
186
Monterrey, , Mexico
187
Monterrey, , Mexico
188
Monterrey, , Mexico
182
Polanco, , Mexico
815
Bucharest, , Romania
810
Cluj-Napoca, , Romania
814
Oradea, , Romania
813
Târgu Mureş, , Romania
830
Kazan', , Russia
831
Kazan', , Russia
834
Moscow, , Russia
833
Novosibirsk, , Russia
598
Terrassa, Barcelona, Spain
592
Almería, , Spain
597
Bajo Sevilla, , Spain
590
Barcelona, , Spain
596
Santiago de Compostela, , Spain
594
Valencia, , Spain
599
Valladolid, , Spain
892
Lausanne, , Switzerland
713
Adana, , Turkey (Türkiye)
714
Ankara, , Turkey (Türkiye)
710
Eskişehir, , Turkey (Türkiye)
711
Istanbul, , Turkey (Türkiye)
719
Istanbul, , Turkey (Türkiye)
717
Izmir, , Turkey (Türkiye)
718
Trabzon, , Turkey (Türkiye)
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2009-011181-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0954
Identifier Type: -
Identifier Source: org_study_id
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