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To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

Primary Purpose

Partial Epilepsies

Status
Completed
Phase
Phase 2
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 Partial Epilepsies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

  • Receiving any study drug or experimental device other than lacosamide.
  • Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide

Arm Description

50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing

Outcomes

Primary Outcome Measures

Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.

Secondary Outcome Measures

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency

Full Information

First Posted
October 30, 2007
Last Updated
June 20, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00552305
Brief Title
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Official Title
An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
During the Treatment Period (up to 8 years)
Title
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
During the Treatment Period (up to 8 years)
Title
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
Description
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Time Frame
During the Treatment Period (up to 8 years)
Secondary Outcome Measure Information:
Title
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
Description
Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Time Frame
Baseline, End of Treatment Period (up to 8 years)
Title
Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
Description
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Time Frame
Treatment Period (up to 8 years)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completion of parent clinical trial for treatment of partial seizures. Exclusion Criteria: Receiving any study drug or experimental device other than lacosamide. Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.
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:
City
Birmingham
State/Province
Alabama
Country
United States
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Huntsville
State/Province
Alabama
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United States
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Phoenix
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Arizona
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United States
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Tucson
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Arizona
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United States
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Little Rock
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Arkansas
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Los Angeles
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California
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Englewood
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Colorado
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Gainesville
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Hollywood
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Miami
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Ponte Vedra Beach
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Chicago
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Illinois
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Springfield
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Indianapolis
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Indiana
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United States
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Iowa City
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Iowa
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Wichita
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Kansas
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United States
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Crestview Hills
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Kentucky
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United States
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Lexington
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Kentucky
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United States
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Baltimore
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Maryland
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United States
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Frederick
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Maryland
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Boston
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Massachusetts
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Ann Arbor
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Michigan
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Detroit
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Saint Paul
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Chesterfield
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Missouri
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Saint Louis
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Missouri
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Somerset
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New Jersey
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United States
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New York
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New York
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Durham
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North Carolina
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Cincinnati
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Ohio
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Cleveland
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Columbus
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Hershey
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United States
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Philadelphia
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Nashville
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Tennessee
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United States
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Dallas
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United States
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Irving
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United States
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Lubbock
State/Province
Texas
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United States
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Wichita Falls
State/Province
Texas
Country
United States
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Bennington
State/Province
Vermont
Country
United States
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Charlottesville
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Virginia
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United States
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Marshfield
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Wisconsin
Country
United States
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Milwaukee
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Wisconsin
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United States
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Bonn
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Germany
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Erlangen
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Germany
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Kehl Kork
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Germany
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Schwalmstedt-Treysa
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Germany
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Budapest
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Hungary
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Zalaegerszeg
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Hungary
City
Kaunas
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Poznan
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Poland
City
Goteborg
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Sweden
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Stockholm
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Sweden
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Bern/Biel
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Switzerland
City
Zurich
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Switzerland
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Bucks/London
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United Kingdom
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Glasgow
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United Kingdom
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25461210
Citation
Rosenfeld W, Fountain NB, Kaubrys G, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP615 Study Investigators. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014 Dec;41:164-70. doi: 10.1016/j.yebeh.2014.09.074. Epub 2014 Oct 27.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

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