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Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF)

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ClinicalTrials.gov Identifier: NCT01235403
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : January 24, 2013
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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 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


Condition or disease Intervention/treatment Phase
Partial Epilepsies Drug: Lacosamide Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Lacosamide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lacosamide
Flexible dosing between 200mg/day and 400mg/day
 Drug: 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 Name: Vimpat®


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235403


Locations
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France
Amiens, France
Aubenas, France
Auxerre, France
Bordeaux, France
Brest, France
Caen, France
Carpentras, France
Chateaubriand, 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-Malo, France
St Brieuc, France
Toulouse, France
Vienne, France
Villeurbanne, France
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Additional Information:

Publications of Results:

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01235403    
Other Study ID Numbers: SP1007
2010-019268-35 ( EudraCT Number )
First Posted: November 5, 2010    Key Record Dates
Results First Posted: January 24, 2013
Last Update Posted: May 21, 2018
Last Verified: March 2018
Keywords provided by UCB Pharma:
Epilepsy treatment.
Anti-epileptic drugs
Seizures
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
 Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action