Trial record 1 of 1 for:    NCT00530855
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Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00530855
First received: September 14, 2007
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Phase 3

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 Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Incidence of Subjects on Lacosamide (LCM) Monotherapy From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]
  • Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]

    A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.

    An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).


  • Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ] [ Designated as safety issue: No ]

    A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.

    An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).



Enrollment: 322
Study Start Date: February 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
Lacosamide tablets for dosing 100 -800 mg/day
Drug: Lacosamide
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Other Name: Vimpat

  Eligibility

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

Inclusion Criteria:

  • Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria:

  • Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
  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: NCT00530855

  Hide Study Locations
Locations
United States, Alabama
048
Alabaster, Alabama, United States
010
Birmingham, Alabama, United States
042
Northport, Alabama, United States
United States, Arizona
009
Phoenix, Arizona, United States
014
Phoenix, Arizona, United States
151
Phoenix, Arizona, United States
103
Tucson, Arizona, United States
United States, Arkansas
102
Jonesboro, Arkansas, United States
007
Little Rock, Arkansas, United States
086
Little Rock, Arkansas, United States
United States, California
120
La Habra, California, United States
059
Los Angeles, California, United States
021
Santa Monica, California, United States
107
Torrance, California, United States
United States, Colorado
060
Aurora, Colorado, United States
United States, Connecticut
025
Fairfield, Connecticut, United States
United States, Florida
094
Doral, Florida, United States
108
Gainesville, Florida, United States
123
Miami, Florida, United States
132
Miami, Florida, United States
077
Orlando, Florida, United States
049
Panama City, Florida, United States
129
Port Charlotte, Florida, United States
050
Sarasota, Florida, United States
004
Tallahassee, Florida, United States
United States, Georgia
079
Atlanta, Georgia, United States
United States, Idaho
058
Boise, Idaho, United States
United States, Illinois
131
Hines, Illinois, United States
146
Peoria, Illinois, United States
011
Springfield, Illinois, United States
United States, Indiana
078
Indianapolis, Indiana, United States
United States, Iowa
073
Ames, Iowa, United States
United States, Kansas
124
Manhattan, Kansas, United States
023
Wichita, Kansas, United States
160
Wichita, Kansas, United States
United States, Kentucky
164
Lexington, Kentucky, United States
062
Louisville, Kentucky, United States
United States, Maine
029
Scarborough, Maine, United States
United States, Maryland
020
Baltimore, Maryland, United States
034
Baltimore, Maryland, United States
065
Pikesville, Maryland, United States
137
Waldorf, Maryland, United States
United States, Michigan
041
Detroit, Michigan, United States
United States, Minnesota
030
Golden Valley, Minnesota, United States
United States, Mississippi
071
Hattiesburg, Mississippi, United States
United States, Missouri
031
Chesterfield, Missouri, United States
066
St Louis, Missouri, United States
United States, New Hampshire
017
Lebanon, New Hampshire, United States
United States, New Jersey
067
Voorhees, New Jersey, United States
United States, New York
036
Albany, New York, United States
083
Buffalo, New York, United States
069
Cedarhurst, New York, United States
027
New York, New York, United States
122
New York, New York, United States
United States, North Carolina
003
Asheville, North Carolina, United States
063
Durham, North Carolina, United States
117
Wilmington, North Carolina, United States
United States, Ohio
015
Cleveland, Ohio, United States
061
Columbus, Ohio, United States
002
Toledo, Ohio, United States
United States, Oklahoma
147
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
100
Greensburg, Pennsylvania, United States
032
Philadelphia, Pennsylvania, United States
United States, South Carolina
024
Beaufort, South Carolina, United States
United States, Tennessee
114
Chattanooga, Tennessee, United States
001
Nashville, Tennessee, United States
United States, Texas
138
Austin, Texas, United States
022
Dallas, Texas, United States
046
El Paso, Texas, United States
051
Houston, Texas, United States
053
Houston, Texas, United States
098
San Antonio, Texas, United States
United States, Utah
136
Layton, Utah, United States
United States, Virginia
161
Alexandria, Virginia, United States
016
Charlottesville, Virginia, United States
United States, Washington
074
Renton, Washington, United States
United States, Wisconsin
080
Madison, Wisconsin, United States
Australia, New South Wales
421
Capmerdown, New South Wales, Australia
425
Chatswood, New South Wales, Australia
Australia, Queensland
423
Herston, Queensland, Australia
Australia, South Australia
420
Adelaide, South Australia, Australia
Australia, Victoria
427
Parkville, Victoria, Australia
Canada, Nova Scotia
140
Halifax, Nova Scotia, Canada
Canada, Ontario
116
Hamilton, Ontario, Canada
093
London, Ontario, Canada
Canada, Quebec
091
Greenfield Park, Quebec, Canada
113
Montreal, Quebec, Canada
110
Montreal, Quebec, Canada
Canada
127
Calgary, Canada
Denmark
223
Aarhus, Denmark
Germany
461
Mainz, Germany
Italy
443
Ferrara, Italy
445
Reggio Calabria, Italy
447
Torrette Di Ancona, Italy
Poland
284
Czestochowa, Poland
286
Gdansk, Poland
282
Gdynia, Poland
280
Krakow, Poland
290
Lublin, Poland
289
Szczecin, Poland
281
Warszawa, Poland
287
Warszawa, Poland
Spain
324
Santa Cruz de Tenerife, Spain
United Kingdom
360
Blackpool, United Kingdom
367
Cornwall, United Kingdom
364
London, United Kingdom
369
London, United Kingdom
363
Middlesborough, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00530855     History of Changes
Other Study ID Numbers: SP904
Study First Received: September 14, 2007
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB Pharma:
Epilepsy
Partial-onset Seizures
Lacosamide
Monotherapy
Vimpat

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014