Back to resultsTrial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
Primary Purpose
Partial Epilepsies
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Partial Epilepsies focused on measuring Epilepsy Treatment, Anti-epileptic drugs, Seizures, Vimpat
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First Add-on
Later Add-on
Arm Description
Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00955357
Brief Title
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
Official Title
An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsies
Keywords
Epilepsy Treatment, Anti-epileptic drugs, Seizures, Vimpat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Add-on
Arm Type
Experimental
Arm Description
Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
Arm Title
Later Add-on
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
SPM927, Harkoseride, Vimpat
Intervention Description
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
Primary Outcome Measure Information:
Title
The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase
Description
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.
Time Frame
From Week 7 (end of Week 6) to end of Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
103
City
Irvine
State/Province
California
Country
United States
Facility Name
123
City
Rancho Mirage
State/Province
California
Country
United States
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156
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Clearwater
State/Province
Florida
Country
United States
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157
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Destin
State/Province
Florida
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United States
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140
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Hollywood
State/Province
Florida
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United States
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161
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Ocala
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Florida
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United States
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108
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Atlanta
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Georgia
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United States
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112
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Atlanta
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Georgia
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United States
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124
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Augusta
State/Province
Georgia
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United States
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115
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Macon
State/Province
Georgia
Country
United States
Facility Name
118
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Rome
State/Province
Georgia
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United States
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128
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Flossmoor
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Illinois
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United States
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130
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Des Moines
State/Province
Iowa
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United States
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102
City
Bowling Green
State/Province
Kentucky
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United States
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117
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Paducah
State/Province
Kentucky
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United States
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107
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Houma
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Louisiana
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United States
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145
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Ruston
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Louisiana
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United States
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101
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Annapolis
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Maryland
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United States
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162
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Waldorf
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Maryland
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United States
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153
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Boston
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Massachusetts
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United States
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136
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Pittsfield
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Massachusetts
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United States
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144
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Springfield
State/Province
Massachusetts
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United States
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151
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Kansas City
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Missouri
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United States
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114
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Paterson
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New Jersey
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United States
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109
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Brooklyn
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New York
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United States
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133
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Brooklyn
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New York
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United States
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127
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West Seneca
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New York
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United States
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158
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Charlotte
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North Carolina
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United States
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139
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Bismarck
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North Dakota
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United States
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134
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Akron
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Ohio
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United States
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150
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Canton
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Ohio
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United States
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141
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Tulsa
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Oklahoma
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United States
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121
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Indiana
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Pennsylvania
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United States
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120
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Columbia
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South Carolina
Country
United States
Facility Name
149
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Orangeburg
State/Province
South Carolina
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United States
Facility Name
152
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Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
148
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Austin
State/Province
Texas
Country
United States
Facility Name
154
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Dallas
State/Province
Texas
Country
United States
Facility Name
146
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Tomball
State/Province
Texas
Country
United States
Facility Name
119
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Fredericksburg
State/Province
Virginia
Country
United States
Facility Name
503
City
Wien
Country
Austria
Facility Name
703
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Blagoevrad
Country
Bulgaria
Facility Name
706
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Pleven
Country
Bulgaria
Facility Name
700
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Sofia
Country
Bulgaria
Facility Name
702
City
Sofia
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Bulgaria
Facility Name
704
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Sofia
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Bulgaria
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705
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Sofia
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Bulgaria
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707
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Sofia
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Bulgaria
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708
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Sofia
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Bulgaria
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701
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Varna
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Bulgaria
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736
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Hradec Kralove
Country
Czechia
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735
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Litomerice
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Czechia
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732
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Ostrava-Hrabuvka
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Czechia
Facility Name
733
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Ostrava
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Czechia
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737
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Praha 11
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Czechia
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734
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Trutnov
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Czechia
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930
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Aarhus
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Denmark
Facility Name
400
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Helsinki
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Finland
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402
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Oulu
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Finland
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401
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Tampere
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Finland
Facility Name
610
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Strasbourg
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France
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611
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Toulon
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France
Facility Name
521
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Athens
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Greece
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520
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Thessaloniki
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Greece
Facility Name
552
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Faenza
Country
Italy
Facility Name
546
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Gallarate
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Italy
Facility Name
541
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Napoli
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Italy
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559
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Pietra Ligure
Country
Italy
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557
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Prato
Country
Italy
Facility Name
540
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Roma
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Italy
Facility Name
549
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Roma
Country
Italy
Facility Name
542
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Taranto
Country
Italy
Facility Name
547
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Torino
Country
Italy
Facility Name
551
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Trieste
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Italy
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180
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Aguascalientes
Country
Mexico
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183
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Chihuahua
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Mexico
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185
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Chihuahua
Country
Mexico
Facility Name
184
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Ciudad Juarez
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Mexico
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189
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Guadalajara
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Mexico
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181
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Mexico DF
Country
Mexico
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193
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Mexico DF
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Mexico
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195
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Mexico DF
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Mexico
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186
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Monterrey
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Mexico
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187
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Monterrey
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Mexico
Facility Name
188
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Monterrey
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Mexico
Facility Name
182
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Polanco
Country
Mexico
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815
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Bucarest
Country
Romania
Facility Name
810
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Cluj-napoca
Country
Romania
Facility Name
814
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Oradea
Country
Romania
Facility Name
813
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Targu Mures
Country
Romania
Facility Name
830
City
Kazan
Country
Russian Federation
Facility Name
831
City
Kazan
Country
Russian Federation
Facility Name
834
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Moscow
Country
Russian Federation
Facility Name
833
City
Novosibirsk
Country
Russian Federation
Facility Name
598
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Terrassa
State/Province
Barcelona
Country
Spain
Facility Name
592
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Almeria
Country
Spain
Facility Name
597
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Bajo Sevilla
Country
Spain
Facility Name
590
City
Barcelona
Country
Spain
Facility Name
596
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Santiago de Compostela
Country
Spain
Facility Name
594
City
Valencia
Country
Spain
Facility Name
599
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Valladolid
Country
Spain
Facility Name
892
City
Lausanne
Country
Switzerland
Facility Name
713
City
Adana
Country
Turkey
Facility Name
714
City
Ankara
Country
Turkey
Facility Name
710
City
Eskisehir
Country
Turkey
Facility Name
711
City
Istanbul
Country
Turkey
Facility Name
719
City
Istanbul
Country
Turkey
Facility Name
717
City
Izmir
Country
Turkey
Facility Name
718
City
Trabzon
Country
Turkey
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
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