- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235403
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF)
A Multicenter, Open Label Study to Evaluate the Tolerability, Safety and Efficacy of Lacosamide (200mg - 400mg/Day) as add-on Therapy for Patients With Partial Onset Epilepsy Using a Flexible Dose-escalation Schedule and Individualized Maintenance Doses
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 safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.
Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Amiens, France
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Aubenas, France
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Auxerre, France
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Bordeaux, France
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Brest, France
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Caen, France
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Carpentras, France
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Chateaubriand, France
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Colmar, France
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Créteil, France
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Gap, France
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Gonesse, France
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La Rochelle, France
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Laval, France
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Limoges, France
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Marseille, France
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Montluçon, France
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Nice, France
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Nîmes, France
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Paris, France
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Perpignan, France
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Poitiers, France
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Pringy, France
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Rennes, France
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Rouen, France
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Saint Aubin Sur Cie, France
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Saint Julien En Gengvois, France
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Saint-Malo, France
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St Brieuc, France
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Toulouse, France
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Vienne, France
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Villeurbanne, France
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lacosamide
Flexible dosing between 200mg/day and 400mg/day
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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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study
Time Frame: During the study ( up to 24 - 28 weeks)
|
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study.
The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
|
During the study ( up to 24 - 28 weeks)
|
Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study
Time Frame: During the study (up to 24 - 28 weeks)
|
Number of subjects prematurely discontinuing due to a TEAE during the study.
The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
|
During the study (up to 24 - 28 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period
Time Frame: End of Treatment Period (24-week)
|
The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase. |
End of Treatment Period (24-week)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP1007
- 2010-019268-35 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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