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Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515619
First Posted: August 14, 2007
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  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: Intervention Model: Single Group Assignment
Masking: None (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 Pharma:

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) ]
    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) ]
    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) ]
    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) ]

    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) ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
Czechia
Brno, Czechia
Hradec Kralove, Czechia
Olomouc, Czechia
Ostrava-Trebovice, Czechia
Plzen, Czechia
Prague, Czechia
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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00515619     History of Changes
Other Study ID Numbers: SP0774
2004-000152-16 ( EudraCT Number )
First Submitted: August 13, 2007
First Posted: August 14, 2007
Results First Submitted: August 5, 2011
Results First Posted: September 9, 2011
Last Update Posted: August 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants