Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
- Registration Number
- NCT00955357
- Lead Sponsor
- UCB Pharma
- Brief Summary
To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.
- Detailed Description
The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 461
Group 1:
- 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
- Previous use of Lacosamide
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description First Add-on Lacosamide Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug \[AED\] polytherapy) and epilepsy diagnosis \< or = 24 months at Screening. Later Add-on Lacosamide 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.
- Primary Outcome Measures
Name Time Method The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase From Week 7 (end of Week 6) to end of Week 18 A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.
This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (109)
703
🇧🇬Blagoevrad, Bulgaria
706
🇧🇬Pleven, Bulgaria
700
🇧🇬Sofia, Bulgaria
704
🇧🇬Sofia, Bulgaria
707
🇧🇬Sofia, Bulgaria
123
🇺🇸Rancho Mirage, California, United States
103
🇺🇸Irvine, 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
124
🇺🇸Augusta, Georgia, United States
112
🇺🇸Atlanta, Georgia, United States
115
🇺🇸Macon, Georgia, United States
130
🇺🇸Des Moines, Iowa, United States
128
🇺🇸Flossmoor, Illinois, United States
118
🇺🇸Rome, Georgia, United States
102
🇺🇸Bowling Green, Kentucky, United States
117
🇺🇸Paducah, Kentucky, United States
107
🇺🇸Houma, Louisiana, United States
145
🇺🇸Ruston, Louisiana, United States
162
🇺🇸Waldorf, Maryland, United States
101
🇺🇸Annapolis, Maryland, United States
136
🇺🇸Pittsfield, Massachusetts, United States
144
🇺🇸Springfield, Massachusetts, United States
109
🇺🇸Brooklyn, New York, United States
114
🇺🇸Paterson, New Jersey, United States
127
🇺🇸West Seneca, New York, United States
133
🇺🇸Brooklyn, New York, United States
158
🇺🇸Charlotte, North Carolina, United States
134
🇺🇸Akron, Ohio, United States
141
🇺🇸Tulsa, Oklahoma, United States
150
🇺🇸Canton, Ohio, United States
121
🇺🇸Indiana, Pennsylvania, United States
149
🇺🇸Orangeburg, South Carolina, United States
120
🇺🇸Columbia, South Carolina, United States
152
🇺🇸Spartanburg, South Carolina, United States
154
🇺🇸Dallas, Texas, United States
146
🇺🇸Tomball, Texas, United States
119
🇺🇸Fredericksburg, Virginia, United States
503
🇦🇹Wien, Austria
702
🇧🇬Sofia, Bulgaria
701
🇧🇬Varna, Bulgaria
735
🇨🇿Litomerice, Czechia
732
🇨🇿Ostrava-Hrabuvka, Czechia
708
🇧🇬Sofia, Bulgaria
400
🇫🇮Helsinki, Finland
402
🇫🇮Oulu, Finland
733
🇨🇿Ostrava, Czechia
734
🇨🇿Trutnov, Czechia
930
🇩🇰Aarhus, Denmark
401
🇫🇮Tampere, Finland
610
🇫🇷Strasbourg, France
611
🇫🇷Toulon, France
521
🇬🇷Athens, Greece
520
🇬🇷Thessaloniki, Greece
552
🇮🇹Faenza, Italy
559
🇮🇹Pietra Ligure, Italy
546
🇮🇹Gallarate, Italy
551
🇮🇹Trieste, Italy
180
🇲🇽Aguascalientes, Mexico
183
🇲🇽Chihuahua, Mexico
184
🇲🇽Ciudad Juarez, Mexico
185
🇲🇽Chihuahua, Mexico
189
🇲🇽Guadalajara, Mexico
181
🇲🇽Mexico DF, Mexico
193
🇲🇽Mexico DF, Mexico
195
🇲🇽Mexico DF, Mexico
186
🇲🇽Monterrey, Mexico
187
🇲🇽Monterrey, Mexico
188
🇲🇽Monterrey, Mexico
182
🇲🇽Polanco, Mexico
815
🇷🇴Bucarest, Romania
810
🇷🇴Cluj-napoca, Romania
830
🇷🇺Kazan, Russian Federation
814
🇷🇴Oradea, Romania
813
🇷🇴Targu Mures, Romania
831
🇷🇺Kazan, Russian Federation
834
🇷🇺Moscow, Russian Federation
833
🇷🇺Novosibirsk, Russian Federation
598
🇪🇸Terrassa, Barcelona, Spain
592
🇪🇸Almeria, 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
714
🇹🇷Ankara, Turkey
711
🇹🇷Istanbul, Turkey
710
🇹🇷Eskisehir, Turkey
719
🇹🇷Istanbul, Turkey
717
🇹🇷Izmir, Turkey
718
🇹🇷Trabzon, Turkey
153
🇺🇸Boston, Massachusetts, United States
705
🇧🇬Sofia, Bulgaria
736
🇨🇿Hradec Kralove, Czechia
737
🇨🇿Praha 11, Czechia
139
🇺🇸Bismarck, North Dakota, United States
541
🇮🇹Napoli, Italy
557
🇮🇹Prato, Italy
540
🇮🇹Roma, Italy
549
🇮🇹Roma, Italy
542
🇮🇹Taranto, Italy
547
🇮🇹Torino, Italy
151
🇺🇸Kansas City, Missouri, United States
148
🇺🇸Austin, Texas, United States