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

June 20, 2018 updated by: UCB Pharma

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
From Visit 1 to End of Study (approximately 2 years)
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)
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
From Visit 1 to End of Study (approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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).
From Visit 1 to End of Study (approximately 2 years)
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)
From Visit 1 to End of Study (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 14, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (Estimate)

September 18, 2007

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0904
  • 2007-005440-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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