A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Partial; Epilepsies

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367432

N01222

2014-004334-26 (EudraCT Number)

Details and patient eligibility

About

This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 [NCT00160165] or N01221 [NCT00280696].

Enrollment: 398 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615]

Exclusion criteria

• Female patients during pregnancy, delivery and lactation, or suspected of pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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398 participants in 1 patient group

Levetiracetam

Experimental group

Description:

Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Treatment:

Drug: Levetiracetam