Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures
2 other identifiers
interventional
461
15 countries
109
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2009
Longer than P75 for phase_4
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
May 1, 2014
CompletedJuly 17, 2018
July 1, 2017
3.7 years
August 6, 2009
March 28, 2014
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase
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.
From Week 7 (end of Week 6) to end of Week 18
Study Arms (2)
First Add-on
EXPERIMENTALLacosamide added to first adequate monotherapy (no history of Antiepileptic Drug \[AED\] polytherapy) and epilepsy diagnosis \< or = 24 months at Screening.
Later Add-on
EXPERIMENTALLacosamide 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (109)
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)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 10, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2013
Study Completion
August 1, 2013
Last Updated
July 17, 2018
Results First Posted
May 1, 2014
Record last verified: 2017-07