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Trial record 1 of 1 for:    NCT00368069
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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
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Keppra® extended release formulation - XR Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
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
placebo
Drug: Placebo
oral tablets, 2 tablets once daily




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. POS Seizure Frequency Per Week Over Baseline and Treatment Period [ Time Frame: Baseline Period (8 weeks) - Treatment Period (12 weeks) ]
  2. 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)

  3. 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.

  4. 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.



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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
Publications of Results:
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00368069    
Other Study ID Numbers: N01235
2006-000987-10 ( EudraCT Number )
First Posted: August 24, 2006    Key Record Dates
Results First Posted: July 28, 2009
Last Update Posted: July 15, 2020
Last Verified: June 2020
Keywords provided by UCB Pharma:
Epilepsy
Keppra® XR
Levetiracetam XR
Extended release
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents