Conversion to Monotherapy Study With Keppra XR for Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00419094
First received: January 4, 2007
Last updated: August 30, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Epilepsy
Drug: Keppra XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase [ Time Frame: 112 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 112 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 112 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 112 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 228
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Keppra XR
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
Other Name: Keppra XR

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419094

  Show 46 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
  More Information

Additional Information:
No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00419094     History of Changes
Other Study ID Numbers: N01280
Study First Received: January 4, 2007
Results First Received: September 13, 2010
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by UCB, Inc.:
Keppra XR
conversion to monotherapy
partial seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on July 20, 2014