Trial record 1 of 1 for:    NCT00515619
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Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00515619
First received: August 13, 2007
Last updated: September 8, 2011
Last verified: August 2011
  Purpose

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

Resource links provided by NLM:


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 Treatment Period (up to 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
    A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.


Secondary Outcome Measures:
  • Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years) [ Time Frame: Baseline, Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]

    Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.

    Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.


  • Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years) [ Time Frame: Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
    At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency


Enrollment: 376
Study Start Date: December 2004
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Drug: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Other Names:
  • SPM 927
  • LCM

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Epilepsy
  • completion of double blind trial

Exclusion Criteria:

  • taking other investigational drug than Lacosamide
  • meeting withdrawal criteria from double blind trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515619

  Hide Study Locations
Locations
Australia, New South Wales
Randwick, New South Wales, Australia
Australia, Queensland
Maroochydore, Queensland, Australia
Australia, South Australia
Woodville, South Australia, Australia
Australia, Victoria
Clayton, Victoria, Australia
Parkville, Victoria, Australia
West Heidelberg, Victoria, Australia
Australia
Adelaide, Australia
Croatia
Zagreb, Croatia
Czech Republic
Brno, Czech Republic
Hradec Kralove, Czech Republic
Olomouc, Czech Republic
Ostrava-Trebovice, Czech Republic
Plzen, Czech Republic
Prague, Czech Republic
Finland
Helsinki, Finland
Kuopio, Finland
Oulu, Finland
Tampere, Finland
France
Lille, France
Lyon, France
Montpellier, France
Paris, France
Toulouse, France
Germany
Berlin, Germany
Erlangen, Germany
Göttingen, Germany
Marburg, Germany, 35039
München, Germany
Ulm, Germany
Hungary
Budapest, Hungary
Pécs, Hungary
Szeged, Hungary
Szombathely, Hungary
Lithuania
Kaunas, Lithuania
Vilnius, Lithuania
Poland
Bialystok, Poland
Gdansk, Poland
Krakow, Poland
Warsaw, Poland
Russian Federation
Moscow, Russian Federation
St. Petersburg, Russian Federation
Spain
Girona, Spain
Granada, Spain
Madrid, Spain
Zaragoza, Spain
Sweden
Gothenburg, Sweden
Linköping, Sweden
Stockholm, Sweden
United Kingdom
Cardiff, United Kingdom
Dundee, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Salford, United Kingdom
Swansea, United Kingdom
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00515619     History of Changes
Other Study ID Numbers: SP774
Study First Received: August 13, 2007
Results First Received: August 5, 2011
Last Updated: September 8, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 08, 2014