A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.
2 other identifiers
interventional
158
7 countries
34
Brief Summary
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
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 Aug 2006
Shorter than P25 for phase_3
34 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
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 11, 2006
CompletedFirst Posted
Study publicly available on registry
August 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedResults Posted
Study results publicly available
July 28, 2009
CompletedJuly 15, 2020
June 1, 2020
9 months
August 11, 2006
April 1, 2009
June 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
Number of POS over the treatment period standardized to 1 week period.
Treatment period (12 weeks)
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
Number of POS over the treatment period standardized to 1 week period
Treatment Period (12 weeks)
Secondary Outcomes (4)
POS Seizure Frequency Per Week Over Baseline and Treatment Period
Baseline Period (8 weeks) - Treatment Period (12 weeks)
All (Type I+II+III) Seizures Frequency Per Week
Treatment period (12 weeks)
50% Response in Weekly POS Frequency
Treatment period (12 weeks)
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
over the treatment period (12 weeks)
Study Arms (2)
Keppra® XR
EXPERIMENTALKeppra® extended release formulation -XR
Placebo
PLACEBO COMPARATORplacebo
Interventions
500mg extended release oral tablet, 2 tablets once daily
Eligibility Criteria
You may qualify if:
- Patients with a confirmed diagnosis of refractory epilepsy
- Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
- Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
You may not qualify if:
- Seizures occurring in clusters
- Status epilepticus within 3 months of Visit 1
- History of non-epileptic seizures
- Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (34)
N01235 1007
Curitiba, Brazil
N01235 2001
Kuopio, Finland
N01235 2003
Tampere, Finland
N01235 2002
Turku, Finland
N01235 3008
Chennai, India
N01235 3010
Chennai, India
N01235 3012
Gandhinagar, India
N01235 3003
Hyderabad, India
N01235 3004
Hyderabad, India
N01235 3001
Lucknow, India
N01235 3009
Madurai, India
N01235 3002
Mumbai, India
N01235 3007
Mumbai, India
N01235 3011
Visakhapatnam, India
N01235 4006
Aguascalientes, Mexico
N01235 4003
Distrio Federal, Mexico
N01235 4001
Guadalajara, Mexico
N01235 4005
Puebla City, Mexico
N01235 5001
Moscow, Russia
N01235 5002
Moscow, Russia
N01235 5003
Moscow, Russia
N01235 5005
Moscow, Russia
N01235 5006
Moscow, Russia
N01235 5007
Moscow, Russia
N01235 5004
Saint Petersburg, Russia
N01235 5009
Saint Petersburg, Russia
N01235 5008
Smolensk, Russia
N01235 6002
Cape Town, South Africa
N01235 6003
Umhlanga, South Africa
N01235 7001
Kharkiv, Ukraine
N01235 7004
Kharkiv, Ukraine
N01235 7005
Lviv, Ukraine
N01235 7002
Odesa, Ukraine
N01235 7003
Poltava, Ukraine
Related Publications (2)
Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.
PMID: 19317886RESULTRichy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.
PMID: 19699156RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2006
First Posted
August 24, 2006
Study Start
August 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
July 15, 2020
Results First Posted
July 28, 2009
Record last verified: 2020-06