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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

228

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Aug 2007

Geographic Reach

4 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

January 4, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed

7 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

December 20, 2010

Completed

Last Updated

September 5, 2014

Status Verified

January 1, 2011

Enrollment Period

2.1 years

First QC Date

January 4, 2007

Results QC Date

September 13, 2010

Last Update Submit

August 26, 2014

Conditions

Epilepsy

Keywords

Keppra XRconversion to monotherapypartial seizures

Outcome Measures

Primary Outcomes (1)

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.
112 days

Secondary Outcomes (3)

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
112 days
The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
112 days
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
112 days

Study Arms (2)

Keppra XR 1000 mg/day

EXPERIMENTAL

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

Drug: Keppra XR

Keppra XR 2000 mg/day

EXPERIMENTAL

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

Drug: Keppra XR

Interventions

Keppra XRDRUG

Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks

Keppra XR 1000 mg/day

Eligibility Criteria

Age12 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

UCB Pharmalead

Study Sites (45)

Unknown Facility

Dothan, Alabama, United States

Location

Unknown Facility

Northport, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Bakersfield, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Loxahatchee Groves, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Suwanee, Georgia, United States

Location

Unknown Facility

Winfield, Illinois, United States

Location

Unknown Facility

Witchita, Kansas, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Bethesda, Maryland, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Camden, New Jersey, United States

Location

Unknown Facility

New Brunswick, New Jersey, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Cedarhurst, New York, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Tulsa, Oklahoma, United States

Location

Unknown Facility

Bend, Oregon, United States

Location

Unknown Facility

Monaca, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Beaufort, South Carolina, United States

Location

Unknown Facility

Monterrey, Nuevo León, Mexico

Location

Unknown Facility

Aguascalientes, Mexico

Location

Unknown Facility

Distrio Federal, Mexico

Location

Unknown Facility

Guadalajara, Mexico

Location

Unknown Facility

Guadalajara Jalisco, Mexico

Location

Unknown Facility

Mexico City, Mexico

Location

Unknown Facility

Monterrey, Mexico

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Szczecin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Kalingrad, Russia

Location

Unknown Facility

Kazan', Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Samara, Russia

Location

Unknown Facility

Yaroslavl, Russia

Location

Related Publications (1)

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.
PMID: 22516508DERIVED

MeSH Terms

Conditions

EpilepsySeizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title: Study Director
Organization: UCB, Inc.

Study Officials

UCB Clinical Trial Call Center
+1 877 822 9493
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 5, 2014

Results First Posted

December 20, 2010

Record last verified: 2011-01

Locations

US(24)ME(7)PL(8)RU(6)

Conversion to Monotherapy Study With Keppra XR for Partial Seizures

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Keppra XR 1000 mg/day

Keppra XR 2000 mg/day

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (45)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Keppra XR 1000 mg/day

Keppra XR 2000 mg/day

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (45)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations