Status:
COMPLETED
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
Lead Sponsor:
UCB Pharma
Conditions:
Partial Epilepsies
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and...
Eligibility Criteria
Inclusion
- Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization
- Currently taking 1 to 3 concomitant marketed antiepileptic drugs
- 18 years and older at study entry
Exclusion
- Previous use of lacosamide
- Hypersensitivity to any component of lacosamide
- Patients with partial onset seizures not clearly identifiable
- History of generalized epilepsy
- History of status epilepticus within last 12 months
- Uncountable seizures due to clustering within last 12 weeks
- Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures
- History of drug or alcohol abuse
- History of suicide attempt
- Progressive cerebral disease
- Concomitant treatment of felbamate
- Prior or concomitant vigabatrin use
- Under legal protection
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01235403
Start Date
June 1 2010
End Date
December 1 2011
Last Update
May 21 2018
Active Locations (32)
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1
Amiens, France
2
Aubenas, France
3
Auxerre, France
4
Bordeaux, France