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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00631150

Enrollment

Registered

2008-03-07

Start date

2003-03-31

Completion date

2004-07-31

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Levetiracetam, Keppra

Brief summary

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.

Interventions

DRUGLevetiracetam (Keppra)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Safety and the tolerability of Keppra in a broad population of patients.	—

Secondary

Measure	Time frame
Obtain further information about optimal daily dose.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026