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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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Partial-onset Seizures, Lacosamide, Monotherapy, Vimpat

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • 048
  • 010
  • 042
  • 009
  • 014
  • 151
  • 103
  • 102
  • 007
  • 086
  • 120
  • 059
  • 021
  • 107
  • 060
  • 025
  • 094
  • 108
  • 123
  • 132
  • 077
  • 049
  • 129
  • 050
  • 004
  • 079
  • 058
  • 131
  • 146
  • 011
  • 078
  • 073
  • 124
  • 023
  • 160
  • 164
  • 062
  • 029
  • 020
  • 034
  • 065
  • 137
  • 041
  • 030
  • 071
  • 031
  • 066
  • 017
  • 067
  • 036
  • 083
  • 069
  • 027
  • 122
  • 003
  • 063
  • 117
  • 015
  • 061
  • 002
  • 147
  • 100
  • 032
  • 024
  • 114
  • 001
  • 138
  • 022
  • 046
  • 051
  • 053
  • 098
  • 136
  • 161
  • 016
  • 074
  • 080
  • 421
  • 425
  • 423
  • 420
  • 427
  • 140
  • 116
  • 093
  • 091
  • 110
  • 113
  • 127
  • 223
  • 461
  • 443
  • 445
  • 447
  • 284
  • 286
  • 282
  • 280
  • 290
  • 289
  • 281
  • 287
  • 324
  • 360
  • 367
  • 364
  • 369
  • 363

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide

Arm Description

Lacosamide tablets for dosing 100 -800 mg/day

Outcomes

Primary Outcome Measures

Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.

Secondary Outcome Measures

Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
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

Full Information

First Posted
September 14, 2007
Last Updated
June 20, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00530855
Brief Title
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Partial-onset Seizures, Lacosamide, Monotherapy, Vimpat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Lacosamide tablets for dosing 100 -800 mg/day
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Primary Outcome Measure Information:
Title
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Description
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Time Frame
From Visit 1 to End of Study (approximately 2 years)
Title
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Description
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Time Frame
From Visit 1 to End of Study (approximately 2 years)
Secondary Outcome Measure Information:
Title
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
Description
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).
Time Frame
From Visit 1 to End of Study (approximately 2 years)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
048
City
Alabaster
State/Province
Alabama
Country
United States
Facility Name
010
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
042
City
Northport
State/Province
Alabama
Country
United States
Facility Name
009
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
014
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
151
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
103
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
102
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
007
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
086
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
120
City
La Habra
State/Province
California
Country
United States
Facility Name
059
City
Los Angeles
State/Province
California
Country
United States
Facility Name
021
City
Santa Monica
State/Province
California
Country
United States
Facility Name
107
City
Torrance
State/Province
California
Country
United States
Facility Name
060
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
025
City
Fairfield
State/Province
Connecticut
Country
United States
Facility Name
094
City
Doral
State/Province
Florida
Country
United States
Facility Name
108
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
123
City
Miami
State/Province
Florida
Country
United States
Facility Name
132
City
Miami
State/Province
Florida
Country
United States
Facility Name
077
City
Orlando
State/Province
Florida
Country
United States
Facility Name
049
City
Panama City
State/Province
Florida
Country
United States
Facility Name
129
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
050
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
004
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
079
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
058
City
Boise
State/Province
Idaho
Country
United States
Facility Name
131
City
Hines
State/Province
Illinois
Country
United States
Facility Name
146
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
011
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
078
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
073
City
Ames
State/Province
Iowa
Country
United States
Facility Name
124
City
Manhattan
State/Province
Kansas
Country
United States
Facility Name
023
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
160
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
164
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
062
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
029
City
Scarborough
State/Province
Maine
Country
United States
Facility Name
020
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
034
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
065
City
Pikesville
State/Province
Maryland
Country
United States
Facility Name
137
City
Waldorf
State/Province
Maryland
Country
United States
Facility Name
041
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
030
City
Golden Valley
State/Province
Minnesota
Country
United States
Facility Name
071
City
Hattiesburg
State/Province
Mississippi
Country
United States
Facility Name
031
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
066
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
017
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
067
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
036
City
Albany
State/Province
New York
Country
United States
Facility Name
083
City
Buffalo
State/Province
New York
Country
United States
Facility Name
069
City
Cedarhurst
State/Province
New York
Country
United States
Facility Name
027
City
New York
State/Province
New York
Country
United States
Facility Name
122
City
New York
State/Province
New York
Country
United States
Facility Name
003
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
063
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
117
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
015
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
061
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
002
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
147
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
100
City
Greensburg
State/Province
Pennsylvania
Country
United States
Facility Name
032
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
024
City
Beaufort
State/Province
South Carolina
Country
United States
Facility Name
114
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
001
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
138
City
Austin
State/Province
Texas
Country
United States
Facility Name
022
City
Dallas
State/Province
Texas
Country
United States
Facility Name
046
City
El Paso
State/Province
Texas
Country
United States
Facility Name
051
City
Houston
State/Province
Texas
Country
United States
Facility Name
053
City
Houston
State/Province
Texas
Country
United States
Facility Name
098
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
136
City
Layton
State/Province
Utah
Country
United States
Facility Name
161
City
Alexandria
State/Province
Virginia
Country
United States
Facility Name
016
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
074
City
Renton
State/Province
Washington
Country
United States
Facility Name
080
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
421
City
Capmerdown
State/Province
New South Wales
Country
Australia
Facility Name
425
City
Chatswood
State/Province
New South Wales
Country
Australia
Facility Name
423
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
420
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
427
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
140
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
116
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
093
City
London
State/Province
Ontario
Country
Canada
Facility Name
091
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
110
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
113
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
127
City
Calgary
Country
Canada
Facility Name
223
City
Aarhus
Country
Denmark
Facility Name
461
City
Mainz
Country
Germany
Facility Name
443
City
Ferrara
Country
Italy
Facility Name
445
City
Reggio Calabria
Country
Italy
Facility Name
447
City
Torrette Di Ancona
Country
Italy
Facility Name
284
City
Czestochowa
Country
Poland
Facility Name
286
City
Gdansk
Country
Poland
Facility Name
282
City
Gdynia
Country
Poland
Facility Name
280
City
Krakow
Country
Poland
Facility Name
290
City
Lublin
Country
Poland
Facility Name
289
City
Szczecin
Country
Poland
Facility Name
281
City
Warszawa
Country
Poland
Facility Name
287
City
Warszawa
Country
Poland
Facility Name
324
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
360
City
Blackpool
Country
United Kingdom
Facility Name
367
City
Cornwall
Country
United Kingdom
Facility Name
364
City
London
Country
United Kingdom
Facility Name
369
City
London
Country
United Kingdom
Facility Name
363
City
Middlesborough
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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