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.
Brief Title
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Partial Epilepsies
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
Epilepsy Treatment
Anti-epileptic drugs
Seizures
Vimpat
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
17 Years
NCT Id
NCT00955357
Org Class
Industry
Org Full Name
UCB Pharma
Org Study Id
SP0954
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome 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.
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.
Outcome Measure
The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase
Outcome Time Frame
From Week 7 (end of Week 6) to end of Week 18
Secondary Ids
Secondary Id
2009-011181-28
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
17
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alexis Boro
Investigator Email
aboro@montefiore.org
Investigator Phone
Categories Mesh Debug
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
EPILEPSIES, PARTIAL
SEIZURES
EPILEPSY
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
LACOSAMIDE
2-(ACETYLAMINO)-3-METHOXY-N-(PHENYLMETHYL)-, (2R)-
ACETAMIDES
AMIDES
ORGANIC CHEMICALS
ACETATES
ACIDS, ACYCLIC
CARBOXYLIC ACIDS