Conversion to Monotherapy Study With Keppra XR for Partial Seizures - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00419094

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: Levetiracetam XR	Phase III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Historical Control, Parallel Assignment, Efficacy Study
Official Title:	A Multi-Center, Double-Blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures

Further study details as provided by UCB:

Primary Outcome Measures:

The primary efficacy endpoint is the cummulative exit rate at 112 days after the beginning of the previous AED tapering phase. [ Time Frame: 112 days ]

Secondary Outcome Measures:

The cumulative rate of exit events, which include discontinuation due to exit criteria, withdrawal due to AE and withdrawal due to lack of efficacy, at 112 days after the beginning of previous AED tapering period. [ Time Frame: 112 days ]
The cumulative rate of exit events due to any reasons at 112 days after the beginning of previous AED tapering period. [ Time Frame: 112 days ]

Estimated Enrollment:	220
Study Start Date:	August 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1000mg/day Levetiracetam XR	Drug: Levetiracetam XR 500mg tablets, 2 x 500mg (1000mg)once daily for 18 weeks
2: Experimental 2000mg/day Levetiracetam XR	Drug: Levetiracetam XR 500mg tablets, 4 x 500mg (2000mg)once daily for 18 weeks

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

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

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Show 56 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01280
Study First Received:	January 4, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00419094
Health Authority:	United States: Food and Drug Administration; Mexico: Ministry of Health; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by UCB:

Keppra XR
conversion to monotherapy
partial seizures

Study placed in the following topic categories:

Epilepsy
Seizures
Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Nervous System Diseases

Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009