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

NCT ID: NCT00530855

Last Updated: 2018-07-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2014-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lacosamide

Lacosamide tablets for dosing 100 -800 mg/day

Group Type EXPERIMENTAL

Lacosamide

Intervention Type DRUG

50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

Interventions

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Lacosamide

50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

Intervention Type DRUG

Other Intervention Names

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Vimpat

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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048

Alabaster, Alabama, United States

Site Status

010

Birmingham, Alabama, United States

Site Status

042

Northport, Alabama, United States

Site Status

009

Phoenix, Arizona, United States

Site Status

014

Phoenix, Arizona, United States

Site Status

151

Phoenix, Arizona, United States

Site Status

103

Tucson, Arizona, United States

Site Status

102

Jonesboro, Arkansas, United States

Site Status

007

Little Rock, Arkansas, United States

Site Status

086

Little Rock, Arkansas, United States

Site Status

120

La Habra, California, United States

Site Status

059

Los Angeles, California, United States

Site Status

021

Santa Monica, California, United States

Site Status

107

Torrance, California, United States

Site Status

060

Aurora, Colorado, United States

Site Status

025

Fairfield, Connecticut, United States

Site Status

094

Doral, Florida, United States

Site Status

108

Gainesville, Florida, United States

Site Status

123

Miami, Florida, United States

Site Status

132

Miami, Florida, United States

Site Status

077

Orlando, Florida, United States

Site Status

049

Panama City, Florida, United States

Site Status

129

Port Charlotte, Florida, United States

Site Status

050

Sarasota, Florida, United States

Site Status

004

Tallahassee, Florida, United States

Site Status

079

Atlanta, Georgia, United States

Site Status

058

Boise, Idaho, United States

Site Status

131

Hines, Illinois, United States

Site Status

146

Peoria, Illinois, United States

Site Status

011

Springfield, Illinois, United States

Site Status

078

Indianapolis, Indiana, United States

Site Status

073

Ames, Iowa, United States

Site Status

124

Manhattan, Kansas, United States

Site Status

023

Wichita, Kansas, United States

Site Status

160

Wichita, Kansas, United States

Site Status

164

Lexington, Kentucky, United States

Site Status

062

Louisville, Kentucky, United States

Site Status

029

Scarborough, Maine, United States

Site Status

020

Baltimore, Maryland, United States

Site Status

034

Baltimore, Maryland, United States

Site Status

065

Pikesville, Maryland, United States

Site Status

137

Waldorf, Maryland, United States

Site Status

041

Detroit, Michigan, United States

Site Status

030

Golden Valley, Minnesota, United States

Site Status

071

Hattiesburg, Mississippi, United States

Site Status

031

Chesterfield, Missouri, United States

Site Status

066

St Louis, Missouri, United States

Site Status

017

Lebanon, New Hampshire, United States

Site Status

067

Voorhees Township, New Jersey, United States

Site Status

036

Albany, New York, United States

Site Status

083

Buffalo, New York, United States

Site Status

069

Cedarhurst, New York, United States

Site Status

027

New York, New York, United States

Site Status

122

New York, New York, United States

Site Status

003

Asheville, North Carolina, United States

Site Status

063

Durham, North Carolina, United States

Site Status

117

Wilmington, North Carolina, United States

Site Status

015

Cleveland, Ohio, United States

Site Status

061

Columbus, Ohio, United States

Site Status

002

Toledo, Ohio, United States

Site Status

147

Oklahoma City, Oklahoma, United States

Site Status

100

Greensburg, Pennsylvania, United States

Site Status

032

Philadelphia, Pennsylvania, United States

Site Status

024

Beaufort, South Carolina, United States

Site Status

114

Chattanooga, Tennessee, United States

Site Status

001

Nashville, Tennessee, United States

Site Status

138

Austin, Texas, United States

Site Status

022

Dallas, Texas, United States

Site Status

046

El Paso, Texas, United States

Site Status

051

Houston, Texas, United States

Site Status

053

Houston, Texas, United States

Site Status

098

San Antonio, Texas, United States

Site Status

136

Layton, Utah, United States

Site Status

161

Alexandria, Virginia, United States

Site Status

016

Charlottesville, Virginia, United States

Site Status

074

Renton, Washington, United States

Site Status

080

Madison, Wisconsin, United States

Site Status

421

Capmerdown, New South Wales, Australia

Site Status

425

Chatswood, New South Wales, Australia

Site Status

423

Herston, Queensland, Australia

Site Status

420

Adelaide, South Australia, Australia

Site Status

427

Parkville, Victoria, Australia

Site Status

140

Halifax, Nova Scotia, Canada

Site Status

116

Hamilton, Ontario, Canada

Site Status

093

London, Ontario, Canada

Site Status

091

Greenfield Park, Quebec, Canada

Site Status

110

Montreal, Quebec, Canada

Site Status

113

Montreal, Quebec, Canada

Site Status

127

Calgary, , Canada

Site Status

223

Aarhus, , Denmark

Site Status

461

Mainz, , Germany

Site Status

443

Ferrara, , Italy

Site Status

445

Reggio Calabria, , Italy

Site Status

447

Torrette Di Ancona, , Italy

Site Status

284

Częstochowa, , Poland

Site Status

286

Gdansk, , Poland

Site Status

282

Gdynia, , Poland

Site Status

280

Krakow, , Poland

Site Status

290

Lublin, , Poland

Site Status

289

Szczecin, , Poland

Site Status

281

Warsaw, , Poland

Site Status

287

Warsaw, , Poland

Site Status

324

Santa Cruz de Tenerife, , Spain

Site Status

360

Blackpool, , United Kingdom

Site Status

367

Cornwall, , United Kingdom

Site Status

364

London, , United Kingdom

Site Status

369

London, , United Kingdom

Site Status

363

Middlesbrough, , United Kingdom

Site Status

Countries

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United States Australia Canada Denmark Germany Italy Poland Spain United Kingdom

Related Links

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Other Identifiers

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2007-005440-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0904

Identifier Type: -

Identifier Source: org_study_id

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