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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Keppra® extended release formulation - XR
Placebo
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Keppra® XR, Levetiracetam XR, Extended release

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • N01235 1007
  • N01235 2001
  • N01235 2003
  • N01235 2002
  • N01235 3008
  • N01235 3010
  • N01235 3012
  • N01235 3003
  • N01235 3004
  • N01235 3001
  • N01235 3009
  • N01235 3002
  • N01235 3007
  • N01235 3011
  • N01235 4006
  • N01235 4003
  • N01235 4001
  • N01235 4005
  • N01235 5001
  • N01235 5002
  • N01235 5003
  • N01235 5005
  • N01235 5006
  • N01235 5007
  • N01235 5004
  • N01235 5009
  • N01235 5008
  • N01235 6002
  • N01235 6003
  • N01235 7001
  • N01235 7004
  • N01235 7005
  • N01235 7002
  • N01235 7003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Keppra® XR

Placebo

Arm Description

Keppra® extended release formulation -XR

placebo

Outcomes

Primary Outcome Measures

Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
Number of POS over the treatment period standardized to 1 week period.
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
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
All (Type I+II+III) Seizures Frequency Per Week
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
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
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.

Full Information

First Posted
August 11, 2006
Last Updated
June 29, 2020
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00368069
Brief Title
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
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 Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Keppra® XR, Levetiracetam XR, Extended release

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keppra® XR
Arm Type
Experimental
Arm Description
Keppra® extended release formulation -XR
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Keppra® extended release formulation - XR
Other Intervention Name(s)
Levetiracetam XR
Intervention Description
500mg extended release oral tablet, 2 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablets, 2 tablets once daily
Primary Outcome Measure Information:
Title
Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
Description
Number of POS over the treatment period standardized to 1 week period.
Time Frame
Treatment period (12 weeks)
Title
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
Description
Number of POS over the treatment period standardized to 1 week period
Time Frame
Treatment Period (12 weeks)
Secondary Outcome Measure Information:
Title
POS Seizure Frequency Per Week Over Baseline and Treatment Period
Time Frame
Baseline Period (8 weeks) - Treatment Period (12 weeks)
Title
All (Type I+II+III) Seizures Frequency Per Week
Description
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)
Time Frame
Treatment period (12 weeks)
Title
50% Response in Weekly POS Frequency
Description
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.
Time Frame
Treatment period (12 weeks)
Title
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
Description
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.
Time Frame
over the treatment period (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
N01235 1007
City
Curitiba
Country
Brazil
Facility Name
N01235 2001
City
Kuopio
Country
Finland
Facility Name
N01235 2003
City
Tampere
Country
Finland
Facility Name
N01235 2002
City
Turku
Country
Finland
Facility Name
N01235 3008
City
Chennai
Country
India
Facility Name
N01235 3010
City
Chennai
Country
India
Facility Name
N01235 3012
City
Ghandinagar
Country
India
Facility Name
N01235 3003
City
Hyderabad
Country
India
Facility Name
N01235 3004
City
Hyderabad
Country
India
Facility Name
N01235 3001
City
Lucknow
Country
India
Facility Name
N01235 3009
City
Madurai
Country
India
Facility Name
N01235 3002
City
Mumbai
Country
India
Facility Name
N01235 3007
City
Mumbai
Country
India
Facility Name
N01235 3011
City
Visakhapatnam
Country
India
Facility Name
N01235 4006
City
Aguascalientes
Country
Mexico
Facility Name
N01235 4003
City
Distrio Federal
Country
Mexico
Facility Name
N01235 4001
City
Guadalajara
Country
Mexico
Facility Name
N01235 4005
City
Puebla
Country
Mexico
Facility Name
N01235 5001
City
Moscow
Country
Russian Federation
Facility Name
N01235 5002
City
Moscow
Country
Russian Federation
Facility Name
N01235 5003
City
Moscow
Country
Russian Federation
Facility Name
N01235 5005
City
Moscow
Country
Russian Federation
Facility Name
N01235 5006
City
Moscow
Country
Russian Federation
Facility Name
N01235 5007
City
Moscow
Country
Russian Federation
Facility Name
N01235 5004
City
Saint Petersburg
Country
Russian Federation
Facility Name
N01235 5009
City
Saint Petersburg
Country
Russian Federation
Facility Name
N01235 5008
City
Smolensk
Country
Russian Federation
Facility Name
N01235 6002
City
Cape Town
Country
South Africa
Facility Name
N01235 6003
City
Umhlanga
Country
South Africa
Facility Name
N01235 7001
City
Kharkov
Country
Ukraine
Facility Name
N01235 7004
City
Kharkov
Country
Ukraine
Facility Name
N01235 7005
City
Lviv
Country
Ukraine
Facility Name
N01235 7002
City
Odessa
Country
Ukraine
Facility Name
N01235 7003
City
Poltava
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
19317886
Citation
Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.
Results Reference
result
PubMed Identifier
19699156
Citation
Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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