Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01235403
First received: November 3, 2010
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Partial Epilepsies
 Drug: Lacosamide
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Lacosamide
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study [ Time Frame: During the study (up to 24 - 28 weeks) ] [ Designated as safety issue: No ]
    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:
  • Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period [ Time Frame: End of Treatment Period (24-week) ] [ Designated as safety issue: No ]

    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.



Enrollment: 100
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235403

Locations
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-Malo, France
St Aubin sur Cie, France
St Brieuc, France
St Julien en Gengvois, France
Toulouse, France
Vienne, France
Villeurbanne, France
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Product Information  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01235403     History of Changes
Other Study ID Numbers: SP1007, 2010-019268-35
Study First Received: November 3, 2010
Results First Received: December 18, 2012
Last Updated: December 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UCB, Inc.:
Epilepsy treatment.
Anti-epileptic drugs
Seizures

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013