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CompletedNCT00631150Updated Nov 15, 2013

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

A Phase 4 interventional study of Levetiracetam (Keppra) in Epilepsy, sponsored by UCB Pharma. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-11-15.

Sponsored by UCB Pharma · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • Levetiracetam
  • Keppra
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 35 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Interventions

  • DrugLevetiracetam (Keppra)
06

What researchers measure

Primary outcomes

  1. Safety and the tolerability of Keppra in a broad population of patients.

Secondary outcomes

  1. Obtain further information about optimal daily dose.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00631150
Lead sponsor
UCB Pharma
First posted
Mar 7, 2008
Start date
Mar 2003
Primary completion
Jul 2004
Completion
Jul 2004
Last update
Nov 15, 2013

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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