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

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Keppra XR (Levetiracetam XR)

• Registration Number: NCT00419393
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-08
• Study Start: 2007-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-03-25
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-15
• Results First Posted: 2011-07-13
• Last Update Submitted: 2014-08-26
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Keppra XR (Levetiracetam XR)	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)

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)	Duration of the Treatment Period (6 months-2 years)	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)	Duration of the Treatment Period (6 months-2 years)	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	Duration of the Treatment Period (6 months-2 years)	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

Name	Time	Method
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months	Study entry through 12 months	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.
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months	Study entry through 6 months	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.