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

June 29, 2020 updated by: UCB Pharma

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Curitiba, Brazil
        • N01235 1007
  • Finland
      • Kuopio, Finland
        • N01235 2001
      • Tampere, Finland
        • N01235 2003
      • Turku, Finland
        • N01235 2002
  • India
      • Chennai, India
        • N01235 3008
      • Chennai, India
        • N01235 3010
      • Ghandinagar, India
        • N01235 3012
      • Hyderabad, India
        • N01235 3003
      • Hyderabad, India
        • N01235 3004
      • Lucknow, India
        • N01235 3001
      • Madurai, India
        • N01235 3009
      • Mumbai, India
        • N01235 3002
      • Mumbai, India
        • N01235 3007
      • Visakhapatnam, India
        • N01235 3011
  • Mexico
      • Aguascalientes, Mexico
        • N01235 4006
      • Distrio Federal, Mexico
        • N01235 4003
      • Guadalajara, Mexico
        • N01235 4001
      • Puebla, Mexico
        • N01235 4005
  • Russian Federation
      • Moscow, Russian Federation
        • N01235 5001
      • Moscow, Russian Federation
        • N01235 5002
      • Moscow, Russian Federation
        • N01235 5003
      • Moscow, Russian Federation
        • N01235 5005
      • Moscow, Russian Federation
        • N01235 5006
      • Moscow, Russian Federation
        • N01235 5007
      • Saint Petersburg, Russian Federation
        • N01235 5004
      • Saint Petersburg, Russian Federation
        • N01235 5009
      • Smolensk, Russian Federation
        • N01235 5008
  • South Africa
      • Cape Town, South Africa
        • N01235 6002
      • Umhlanga, South Africa
        • N01235 6003
  • Ukraine
      • Kharkov, Ukraine
        • N01235 7001
      • Kharkov, Ukraine
        • N01235 7004
      • Lviv, Ukraine
        • N01235 7005
      • Odessa, Ukraine
        • N01235 7002
      • Poltava, Ukraine
        • N01235 7003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
placebo
Drug: Placebo
oral tablets, 2 tablets once daily
EXPERIMENTAL: Keppra® XR
Keppra® extended release formulation -XR
Drug: Keppra® extended release formulation - XR
500mg extended release oral tablet, 2 tablets once daily
Other Names:
  • Levetiracetam XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Treatment period (12 weeks)
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
Treatment Period (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POS Seizure Frequency Per Week Over Baseline and Treatment Period
Time Frame: Baseline Period (8 weeks) - Treatment Period (12 weeks)
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)
Treatment period (12 weeks)
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.
Treatment period (12 weeks)
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.
over the treatment period (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

August 11, 2006

First Submitted That Met QC Criteria

August 23, 2006

First Posted (ESTIMATE)

August 24, 2006

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01235
  • 2006-000987-10 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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