An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 190
- Primary Endpoint
- Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: Keppra XR (Levetiracetam XR) (Drug)
Outcomes
Primary Outcomes
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)
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)
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)
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 Outcomes
- Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months(Study entry through 12 months)
- Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months(Study entry through 6 months)