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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
322

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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