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 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- UCB Japan Co. Ltd.
- Enrollment
- 352
- Primary Endpoint
- Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:
- •Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
- •Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
- •Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
- •Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks
Exclusion Criteria
- •The following patients are not eligible for inclusion into the study:
- •Subjects who were diagnosed with status epilepticus within 3 months before screening
- •Subjects with no partial seizures of which frequency was measured during the Baseline Period
- •Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
- •Subjects with a history of oral treatment with Levetiracetam (LEV)
Arms & Interventions
Lev 0.5 g
Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Levetiracetam 250 mg (Drug)
Lev 1 g
Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Levetiracetam 250 mg (Drug)
Lev 1 g
Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Levetiracetam 500 mg (Drug)
Lev 2 g
Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Levetiracetam 250 mg (Drug)
Lev 2 g
Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Levetiracetam 500 mg (Drug)
Lev 3 g
Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Levetiracetam 250 mg (Drug)
Lev 3 g
Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Levetiracetam 500 mg (Drug)
Placebo
Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Partial (Type I) seizure frequency per week over the Evaluation Period(12-week Evaluation Period)
- Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period(From Baseline to the 12-week Evaluation Period)
- Seizure freedom over the Evaluation Period(12-week Evaluation Period)
- Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period(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(From Baseline to the 12-week Evaluation Period)