Phase 4
N=456
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
Partial Epilepsies
Bottom Line
View on ClinicalTrials.gov: NCT00955357 ↗Enrolled (actual)
456
Serious AEs
5.9%
Results posted
May 2014
Primary outcome: Primary: The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase — 37.5; 14.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lacosamide (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase |
37.5; 14.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00955357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.