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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00368069
First received: August 11, 2006
Last updated: August 30, 2011
Last verified: December 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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, Inc.:

Primary Outcome Measures:
  • Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population [ Time Frame: Treatment period (12 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • All (Type I+II+III) Seizures Frequency Per Week [ Time Frame: Treatment period (12 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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
placebo
Drug: Placebo
oral tablets, 2 tablets once daily

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368069

Locations
Finland
Kuopio, Finland
Tampere, Finland
Turku, Finland
India
Chennai, India
Hyderbad, India
Lucknow, India
Madurai, India
Mumbai, India
Visakhapatnam, India
Mexico
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
Ukraine
Kharkov, Ukraine
Odessa, Ukraine
Poltava, Ukraine
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB, Inc.
ClinicalTrials.gov 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 30, 2011
Health Authority: Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health
Mexico: Ministry of Health
South Africa: Department of Health
India: Ministry of Health
Finland: Finnish Medicines Agency
Brazil: Ministry of Health

Keywords provided by UCB, Inc.:
Epilepsy
Keppra® XR
Levetiracetam XR
Extended release

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on April 17, 2014