A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
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|ClinicalTrials.gov Identifier: NCT00368069|
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : July 28, 2009
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Keppra® extended release formulation - XR Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
Experimental: Keppra® XR
Keppra® extended release formulation -XR
Drug: Keppra® extended release formulation - XR
500mg extended release oral tablet, 2 tablets once daily
Other Name: Levetiracetam XR
Placebo Comparator: Placebo
oral tablets, 2 tablets once daily
- Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population [ Time Frame: Treatment period (12 weeks) ]Number of POS over the treatment period standardized to 1 week period.
- Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population [ Time Frame: Treatment Period (12 weeks) ]Number of POS over the treatment period standardized to 1 week period
- POS Seizure Frequency Per Week Over Baseline and Treatment Period [ Time Frame: Baseline Period (8 weeks) - Treatment Period (12 weeks) ]
- All (Type I+II+III) Seizures Frequency Per Week [ Time Frame: Treatment period (12 weeks) ]Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)
- 50% Response in Weekly POS Frequency [ Time Frame: Treatment period (12 weeks) ]A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.
- Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks [ Time Frame: over the treatment period (12 weeks) ]The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368069
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|