Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
NCT ID: NCT01235403
Last Updated: 2018-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2010-06-30
2011-12-31
Brief Summary
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Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
Flexible dosing between 200mg/day and 400mg/day
Lacosamide
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks
Interventions
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Lacosamide
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently taking 1 to 3 concomitant marketed antiepileptic drugs
* 18 years and older at study entry
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Amiens, , France
Aubenas, , France
Auxerre, , France
Bordeaux, , France
Brest, , France
Caen, , France
Carpentras, , France
Châteaubriand, , France
Colmar, , France
Créteil, , France
Gap, , France
Gonesse, , France
La Rochelle, , France
Laval, , France
Limoges, , France
Marseille, , France
Montluçon, , France
Nice, , France
Nîmes, , France
Paris, , France
Perpignan, , France
Poitiers, , France
Pringy, , France
Rennes, , France
Rouen, , France
Saint Aubin Sur Cie, , France
Saint Julien En Gengvois, , France
Saint-Brieuc, , France
St-Malo, , France
Toulouse, , France
Vienne, , France
Villeurbanne, , France
Countries
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References
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Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1;19(2):186-194. doi: 10.1684/epd.2017.0907.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2010-019268-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP1007
Identifier Type: -
Identifier Source: org_study_id
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