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Conversion to Monotherapy Study With Keppra XR for Partial Seizures

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Keppra XR
Keppra XR
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 Keppra XR, conversion to monotherapy, partial seizures

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects 12 to 75 years of age.
  • Subjects must have inadequately controlled partial onset epilepsy.
  • Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)

Exclusion Criteria:

  • A history of status epilepticus in the 6 months preceding randomization.
  • Significant medical, psychiatric or neurological illness.
  • Intake of benzodiazepines on more than an occasional basis
  • History of previous treatment with levetiracetam or sensitivity to levetiracetam.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Keppra XR 1000 mg/day

Keppra XR 2000 mg/day

Arm Description

1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)

2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)

Outcomes

Primary Outcome Measures

The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.

Secondary Outcome Measures

The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.
The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.
The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.

Full Information

First Posted
January 4, 2007
Last Updated
August 26, 2014
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00419094
Brief Title
Conversion to Monotherapy Study With Keppra XR for Partial Seizures
Official Title
A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (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
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Keppra XR, conversion to monotherapy, partial seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keppra XR 1000 mg/day
Arm Type
Experimental
Arm Description
1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)
Arm Title
Keppra XR 2000 mg/day
Arm Type
Experimental
Arm Description
2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)
Intervention Type
Drug
Intervention Name(s)
Keppra XR
Intervention Description
Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
Intervention Type
Drug
Intervention Name(s)
Keppra XR
Intervention Description
Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
Primary Outcome Measure Information:
Title
The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Description
Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.
Time Frame
112 days
Secondary Outcome Measure Information:
Title
The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
Description
The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.
Time Frame
112 days
Title
The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
Description
The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.
Time Frame
112 days
Title
The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Description
Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.
Time Frame
112 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects 12 to 75 years of age. Subjects must have inadequately controlled partial onset epilepsy. Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s) Exclusion Criteria: A history of status epilepticus in the 6 months preceding randomization. Significant medical, psychiatric or neurological illness. Intake of benzodiazepines on more than an occasional basis History of previous treatment with levetiracetam or sensitivity to levetiracetam.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493
Official's Role
Study Director
Facility Information:
City
Dothan
State/Province
Alabama
Country
United States
City
Northport
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Loxahatchee
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Suwanee
State/Province
Georgia
Country
United States
City
Winfield
State/Province
Illinois
Country
United States
City
Witchita
State/Province
Kansas
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Camden
State/Province
New Jersey
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
Cedarhurst
State/Province
New York
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Bend
State/Province
Oregon
Country
United States
City
Monaca
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Beaufort
State/Province
South Carolina
Country
United States
City
Monterrey
State/Province
NL
Country
Mexico
City
Aguascalientes
Country
Mexico
City
Distrio federal
Country
Mexico
City
Guadalajara Jalisco
Country
Mexico
City
Guadalajara
Country
Mexico
City
Mexico City
Country
Mexico
City
Monterrey
Country
Mexico
City
Bialystok
Country
Poland
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Lodz
Country
Poland
City
Lublin
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Poland
City
Poznan
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Poland
City
Szczecin
Country
Poland
City
Warszawa
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Poland
City
Kalingrad
Country
Russian Federation
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Samara
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
22516508
Citation
Chung S, Ceja H, Gawlowicz J, Avakyan G, McShea C, Schiemann J, Lu S. Levetiracetam extended release conversion to monotherapy for the treatment of patients with partial-onset seizures: a double-blind, randomised, multicentre, historical control study. Epilepsy Res. 2012 Aug;101(1-2):92-102. doi: 10.1016/j.eplepsyres.2012.03.007. Epub 2012 Apr 18.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

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Conversion to Monotherapy Study With Keppra XR for Partial Seizures

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