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A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

This study has been completed.
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: August 11, 2006
Last updated: August 13, 2015
Last verified: August 2015
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Condition Intervention Phase
Epilepsy Drug: Keppra® extended release formulation - XR Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Enrollment: 158
Study Start Date: August 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
oral tablets, 2 tablets once daily


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

Inclusion Criteria:

  • Patients with a confirmed diagnosis of refractory epilepsy Patients must be receiving 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00368069

Kuopio, Finland
Tampere, Finland
Turku, Finland
Chennai, India
Hyderbad, India
Lucknow, India
Madurai, India
Mumbai, India
Visakhapatnam, India
Aguascalientes, Mexico
Distrio Federal, Mexico
Puebla, Mexico
Russian Federation
Moscow, Russian Federation
Smolensk, Russian Federation
St. Petersburg, Russian Federation
South Africa
Durban, South Africa
Tygeberg, South Africa
Kharkov, Ukraine
Odessa, Ukraine
Poltava, Ukraine
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: UCB Pharma Identifier: NCT00368069     History of Changes
Other Study ID Numbers: N01235
Eudra CT# 2006-000987-10
Study First Received: August 11, 2006
Results First Received: April 1, 2009
Last Updated: August 13, 2015

Keywords provided by UCB Pharma:
Keppra® XR
Levetiracetam XR
Extended release

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents processed this record on June 22, 2017