A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsies, Partial

Treatments: Drug: Levetiracetam 500 mg; Other: Placebo; Drug: Levetiracetam 250 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00280696

N01221

2014-004333-57 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 352 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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352 participants in 5 patient groups, including a placebo group

Lev 0.5 g

Experimental group

Description:

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).

Treatment:

Drug: Levetiracetam 250 mg

Lev 1 g

Experimental group

Description:

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).

Treatment:

Drug: Levetiracetam 500 mg

Drug: Levetiracetam 250 mg

Lev 2 g

Experimental group

Description:

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).

Treatment:

Drug: Levetiracetam 500 mg

Drug: Levetiracetam 250 mg

Lev 3 g

Experimental group

Description:

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).

Treatment:

Drug: Levetiracetam 500 mg

Drug: Levetiracetam 250 mg

Placebo

Placebo Comparator group

Description:

Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

Treatment:

Other: Placebo