Long Term Follow-up Study With Levetiracetam XR (Keppra XR) for Partial Seizures - Full Text View

Purpose

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in patients with partial onset seizures.

Condition	Intervention	Phase
Epilepsy	Drug: Levetiracetam XR	Phase III

Genetics Home Reference related topics:

pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics:

Epilepsy Seizures

ChemIDplus related topics:

Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	An Open-Label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-Onset Seizures

Further study details as provided by UCB:

Primary Outcome Measures:

The primary endpoint is the evaluation of the long-term safety of Keppra XR in patients with partial onset seizures. [ Time Frame: 2 - 3 years ]

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

Arms	Assigned Interventions
1: Experimental 1000 - 3000 mg/day Keppra XR (Levetiracetam XR)	Drug: Levetiracetam XR 500mg tablets 1000 - 3000mg/day flexible dosing duration of the trial

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who were randomized into study N01280 and completed the 2-week up titration period

Exclusion Criteria:

Subjects who did not meet the inclusion/exclusion criteria for N01280.
Subjects who were discontinued prior to the end of titration period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419393

Show 32 Study Locations

Sponsors and Collaborators

UCB

Investigators


Study Director:	UCB Clinical Trial Call Center, MD	+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01281
First Received:	January 4, 2007
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00419393
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health; Mexico: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by UCB:

Keppra XR

Levetiracetam XR

long term

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 September 23, 2008

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00419393