Conversion to Monotherapy Study With Keppra XR for Partial Seizures

• ClinicalTrials.gov Identifier: NCT00419094
• Recruitment Status: Completed
• First Posted: January 8, 2007
• Results First Posted: December 20, 2010
• Last Update Posted: September 5, 2014
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: Keppra XR	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
• Study Start Date: August 2007
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Keppra XR 1000 mg/day; 1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)	Drug: Keppra XR; Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
Experimental: Keppra XR 2000 mg/day; 2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)	Drug: Keppra XR; Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks

Outcome Measures

Primary Outcome Measures :

1. The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase [ Time Frame: 112 days ]
   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 :

1. 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 [ Time Frame: 112 days ]
   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.
2. The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase [ Time Frame: 112 days ]
   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.
3. 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 [ Time Frame: 112 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

Dothan, Alabama, United States

Northport, Alabama, United States

United States, Arizona

Phoenix, Arizona, United States

United States, Arkansas

Little Rock, Arkansas, United States

United States, California

Bakersfield, California, United States

United States, Florida

Jacksonville, Florida, United States

Loxahatchee, Florida, United States

United States, Georgia

Atlanta, Georgia, United States

Suwanee, Georgia, United States

United States, Illinois

Winfield, Illinois, United States

United States, Kansas

Witchita, Kansas, United States

United States, Louisiana

Shreveport, Louisiana, United States

United States, Maryland

Bethesda, Maryland, United States

United States, Michigan

Detroit, Michigan, United States

United States, New Jersey

Camden, New Jersey, United States

New Brunswick, New Jersey, United States

United States, New York

Buffalo, New York, United States

Cedarhurst, New York, United States

United States, Ohio

Toledo, Ohio, United States

United States, Oklahoma

Tulsa, Oklahoma, United States

United States, Oregon

Bend, Oregon, United States

United States, Pennsylvania

Monaca, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

United States, South Carolina

Beaufort, South Carolina, United States

Mexico

Monterrey, NL, Mexico

Aguascalientes, Mexico

Distrio federal, Mexico

Guadalajara Jalisco, Mexico

Guadalajara, Mexico

Mexico City, Mexico

Monterrey, Mexico

Poland

Bialystok, Poland

Gdansk, Poland

Katowice, Poland

Lodz, Poland

Lublin, Poland

Poznan, Poland

Szczecin, Poland

Warszawa, Poland

Russian Federation

Kalingrad, Russian Federation

Kazan, Russian Federation

Moscow, Russian Federation

Samara, Russian Federation

St Petersburg, Russian Federation

St. Petersburg, Russian Federation

Yaroslavl, Russian Federation

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493

More Information

Additional Information:

FDA Safety Alerts and Recalls 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00419094
• Other Study ID Numbers: N01280; 2007-000897-21 ( EudraCT Number )
• First Posted: January 8, 2007
• Results First Posted: December 20, 2010
• Last Update Posted: September 5, 2014
• Last Verified: January 2011

Keywords provided by UCB Pharma:

Keppra XR; conversion to monotherapy; partial seizures

Additional relevant MeSH terms:

Seizures; Nervous System Diseases; Neurologic Manifestations; Levetiracetam; Anticonvulsants; Nootropic Agents