Status:
COMPLETED
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Partial Epilepsies
Eligibility:
All Genders
17+ years
Phase:
PHASE4
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) ...
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-we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT00955357
Start Date
August 1 2009
End Date
August 1 2013
Last Update
July 17 2018
Active Locations (109)
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103
Irvine, California, United States
2
123
Rancho Mirage, California, United States
3
156
Clearwater, Florida, United States
4
157
Destin, Florida, United States