A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

UCB

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: Levetiracetam (Keppra)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631150

N01035

Details and patient eligibility

About

Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Enrollment: 35 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• partial onset seizures with or without secondary generalisation with epilepsy.

Exclusion criteria

• hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)