Clinical Trial: A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 t
Brief Summary: A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.
Detailed Summary:
Sponsor: UCB Japan Co. Ltd.
Current Primary Outcome: Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]
Original Primary Outcome: Percent reduction of partial seizure frequency per week
Current Secondary Outcome:
- Partial (Type I) seizure frequency per week over the Evaluation Period [ Time Frame: 12-week Evaluation Period ]
- Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]
- Seizure freedom over the Evaluation Period [ Time Frame: 12-week Evaluation Period ]
- Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]
- Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]
Original Secondary Outcome:
- Seizures frequency per week
- Safety
Information By: UCB Pharma
Dates:
Date Received: January 19, 2006
Date Started: November 2005
Date Completion:
Last Updated: February 10, 2015
Last Verified: February 2015
