A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
Overview
- Phase
- Phase 3
- Intervention
- Keppra XR
- Conditions
- Epilepsy
- Sponsor
- UCB Pharma
- Enrollment
- 228
- Primary Endpoint
- The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects 12 to 75 years of age.
- •Subjects must have inadequately controlled partial onset epilepsy.
- •Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)
Exclusion Criteria
- •A history of status epilepticus in the 6 months preceding randomization.
- •Significant medical, psychiatric or neurological illness.
- •Intake of benzodiazepines on more than an occasional basis
- •History of previous treatment with levetiracetam or sensitivity to levetiracetam.
Arms & Interventions
Keppra XR 1000 mg/day
1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)
Intervention: Keppra XR
Keppra XR 2000 mg/day
2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)
Intervention: Keppra XR
Outcomes
Primary Outcomes
The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Time Frame: 112 days
Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.
Secondary Outcomes
- The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase(112 days)
- The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase(112 days)
- The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase(112 days)