Back to resultsLong Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Keppra XR (Levetiracetam XR)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Keppra XR, Levetiracetam XR, long term, partial seizures
Eligibility Criteria
Inclusion Criteria:
- Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period
Exclusion Criteria:
- Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
- Subjects who were discontinued prior to the end of titration period
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Keppra XR (Levetiracetam XR)
Arm Description
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Outcomes
Primary Outcome Measures
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 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.
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Secondary Outcome Measures
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419393
Brief Title
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
Official Title
An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Keppra XR, Levetiracetam XR, long term, partial seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Keppra XR (Levetiracetam XR)
Arm Type
Experimental
Arm Description
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Intervention Type
Drug
Intervention Name(s)
Keppra XR (Levetiracetam XR)
Other Intervention Name(s)
Keppra XR
Intervention Description
500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
Primary Outcome Measure Information:
Title
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Description
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time Frame
Duration of the Treatment Period (6 months-2 years)
Title
Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 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
Duration of the Treatment Period (6 months-2 years)
Title
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
Description
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time Frame
Duration of the Treatment Period (6 months-2 years)
Secondary Outcome Measure Information:
Title
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
Description
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.
Time Frame
Study entry through 6 months
Title
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
Description
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.
Time Frame
Study entry through 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period
Exclusion Criteria:
Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
Subjects who were discontinued prior to the end of titration period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center, MD
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Dothan
State/Province
Alabama
Country
United States
City
Northport
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Loxahatchee
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Suwanee
State/Province
Georgia
Country
United States
City
Witchita
State/Province
Kansas
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Camden
State/Province
New Jersey
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
Cedarhurst
State/Province
New York
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Aguascalientes
Country
Mexico
City
Guadalajara Jalisco
Country
Mexico
City
Guadalajara
Country
Mexico
City
Mexico City
Country
Mexico
City
Mexico DF
Country
Mexico
City
Monterrey
Country
Mexico
City
Bialystok
Country
Poland
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Kalingrad
Country
Russian Federation
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Samara
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
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
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
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