Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
2 other identifiers
interventional
190
4 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2007
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2007
CompletedFirst Posted
Study publicly available on registry
January 8, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 13, 2011
CompletedSeptember 5, 2014
June 1, 2011
2.2 years
January 4, 2007
March 25, 2011
August 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Duration of the Treatment Period (6 months-2 years)
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.
Duration of the Treatment Period (6 months-2 years)
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.
Duration of the Treatment Period (6 months-2 years)
Secondary Outcomes (2)
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
Study entry through 6 months
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
Study entry through 12 months
Study Arms (1)
Keppra XR (Levetiracetam XR)
EXPERIMENTAL1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Interventions
500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
Eligibility Criteria
You may qualify if:
- Subjects who were randomized into study N01280 \[NCT00419094\], and completed the 2 week up titration period
You may not qualify if:
- Subjects who were discontinued prior to the end of titration period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (35)
Unknown Facility
Dothan, Alabama, United States
Unknown Facility
Northport, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Loxahatchee Groves, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Suwanee, Georgia, United States
Unknown Facility
Witchita, Kansas, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Camden, New Jersey, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Cedarhurst, New York, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Aguascalientes, Mexico
Unknown Facility
Guadalajara, Mexico
Unknown Facility
Guadalajara Jalisco, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
Monterrey, Mexico
Unknown Facility
Bialystok, Poland
Unknown Facility
Gdansk, Poland
Unknown Facility
Katowice, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Kalingrad, Russia
Unknown Facility
Kazan', Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Yaroslavl, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center, MD
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2007
First Posted
January 8, 2007
Study Start
December 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
September 5, 2014
Results First Posted
July 13, 2011
Record last verified: 2011-06