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

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
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 subjects with partial onset seizures.

Condition	Intervention	Phase
Epilepsy	Drug: Keppra XR (Levetiracetam XR)	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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, Inc.:

Primary Outcome Measures:

Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) [ Time Frame: Duration of the Treatment Period (6 months-2 years) ] [ Designated as safety issue: No ]
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) [ Time Frame: Duration of the Treatment Period (6 months-2 years) ] [ Designated as safety issue: No ]
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period [ Time Frame: Duration of the Treatment Period (6 months-2 years) ] [ Designated as safety issue: No ]
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures:

Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months [ Time Frame: Study entry through 6 months ] [ Designated as safety issue: No ]
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months [ Time Frame: Study entry through 12 months ] [ Designated as safety issue: No ]
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.

Enrollment:	190
Study Start Date:	December 2007
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Keppra XR (Levetiracetam XR) 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)	Drug: Keppra XR (Levetiracetam XR) 500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years). 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:

Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period

Exclusion Criteria:

Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
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 37 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center, MD

+1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Product Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00419393 History of Changes
Other Study ID Numbers:	N01281
Study First Received:	January 4, 2007
Results First Received:	March 25, 2011
Last Updated:	August 30, 2011
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, Inc.:

Keppra XR
Levetiracetam XR
long term
partial seizures

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam

Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012