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

This study is enrolling participants by invitation only.

First Received: January 4, 2007 Last Updated: June 24, 2009 History of Changes

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

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

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

Resource links provided by NLM:

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

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Keppra XR: 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 39 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center, MD

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01281
Study First Received:	January 4, 2007
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00419393 History of Changes
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:

Nootropic Agents
Epilepsy
Seizures
Central Nervous System Diseases

Etiracetam
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Nootropic Agents
Epilepsy
Therapeutic Uses
Nervous System Diseases
Central Nervous System Diseases

Etiracetam
Brain Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on July 02, 2009