An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

NCT00419393 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	UCB Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	190
Start date	2007-12
Completion	2010-03

Conditions

• Epilepsy

Interventions

• Keppra XR (Levetiracetam XR)

Primary outcomes

• 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.

Countries

United States, Mexico, Poland, Russia